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cess/FormsSubmissionRequirements/Electr
onicSubmissions/DataStandardsManualmonographs/
Data Values.
NAME
AEROSOL
DEFINITION
USE
RESTRICTION
S
FDA
SHORT NAME
COD
E
AER
246
NCI
CONCEPT
ID
C42887
A
product
that
is
a,b,c
packaged
under
pressure and contains
therapeutically
active
ingredients
that
are
released
upon
activation
of
an
appropriate
valve
system;
it
is
intended
for topical
application
to
the
skin
as
well
as
local
application
into
the
nose
(nasal
aerosols),
mouth
(lingual
aerosols),
or
lungs
(inhalation
aerosols).
A
dosage
form
a,b,c
containing
one
or
more
active
ingredients,
surfactants,
aqueous
or
nonaqueous
liquids,
and
the
propellants;
if
the
propellant
is
in
the
internal
(discontinuous) phase
(i.e.,
of
the
oil-in-
water
type),
a
stable
foam
is
discharged, and if the
propellant
is
in
the
AEROSOL, FOAM
AER FOAM
800
C42888
external
(continuous)
phase
(i.e.,
of
the
water-in-oil
type),
a
spray
or
a
quick-breaking
foam
is discharged.
AEROSOL,
METERED
A
pressurized
dosage
a,b,c
form
consisting
of
metered
dose
valves
which
allow
for
the
delivery
of
a
uniform
quantity
of
spray
upon
each activation.
A
product
that
is
a,b
packaged
under
pressure and contains
therapeutically
active
ingredients,
in
the
form
of
a
powder,
that
are
released
upon
activation of an
appropriate
valve
system.
An
aerosol
product
a,b
which
utilizes
a
compressed
gas
as
the
propellant
to
provide
the
force
necessary
to
expel
the
product
as
a
wet
spray;
it
is
applicable
to
solutions
of
medicinal
agents
in
aqueous solvents.
A
solid
dosage
form
a,b,c
usually in the form of
a
rectangle
that
is
meant to be chewed.
A
solid
dosage
form
a,b
in
the
shape
of
a
small ball.
AER MET
339
C42960
AEROSOL,
POWDER
AER PWD
801
C42971
AEROSOL, SPRAY
AER SPRAY
247
C42889
BAR, CHEWABLE
BAR CHEW
347
C42892
BEAD
BEAD
317
C42890
BEAD,
IMPLANT,
A
small
sterile
solid
a
EXTENDED
mass
consisting
of
a
RELEASE
highly
purified
drug
intended
for
implantation
in
the
body
which
would
allow
at
least
a
reduction
in
dosing
frequency
as
compared
to
that
drug
presented
as
a
conventional
dosage
form.
BLOCK
Solid
dosage
form,
a,b
usually
in
the
shape
of
a
square
or
rectangle.
A
solid
oral
dosage
a,b,c
form
consisting
of
a
shell and a filling. The
shell is composed of a
single
sealed
enclosure,
or
two
halves
that
fit
together
and
which
are sometimes sealed
with
a
band.
Capsule
shells
may
be
made
from
gelatin,
starch,
or
cellulose,
or
other
suitable
materials,
may
be
soft
or
hard,
and
are
filled
with
solid
or
liquid
ingredients
that
can
be
poured
or
squeezed.
BEAD IMP ER
802
C43451
BLOCK
803
C42891
CAPSULE
CAP
600
C25158
CAPSULE, COATED
A
solid
dosage
form
a,b
in
which
the
drug
is
enclosed
within
either
a
hard
or
soft
soluble
container
or
made
from
a
CAP COATED
602
C42895
suitable
form
of
gelatin;
additionally,
the capsule is covered
in
a
designated
coating.
CAPSULE,
COATED
A
solid
dosage
form
a,b,c
PELLETS
in
which
the
drug
is
enclosed
within
either
a
hard
or
soft
soluble
container
or
made
from
a
suitable
form
of
gelatin; the drug itself
is
in
the
form
of
granules
to
which
varying
amounts
of
coating
have
been
applied.
CAPSULE,
COATED,
A
solid
dosage
form
a,b
EXTENDED
in
which
the
drug
is
RELEASE
enclosed
within
either
a
hard
or
soft
soluble
container
or
made
from
a
suitable
form
of
gelatin;
additionally,
the capsule is
covered
in
a
designated
coating,
and
which
releases
a
drug
(or
drugs)
in
such
a
manner
to
allow
at
least
a
reduction
in
dosing
frequency
as
compared
to
that
drug
(or
drugs)
presented
as
a
conventional
dosage
form.
CAPSULE, DELAYED
A
solid
dosage
form
a,b,c
RELEASE
in
which
the
drug
is
enclosed
within
either
a
hard
or
soft
CAP
COATED
603
PELLETS
C42896
CAP
COATED
611
ER
C42917
CAP DR
620
C42902
soluble
container
made from a suitable
form
of
gelatin,
and
which releases a drug
(or
drugs)
at
a
time
other
than
promptly
after
administration.
Enteric-
coated
articles
are
delayed
release dosage
forms.
CAPSULE, DELAYED
A
solid
dosage
form
a,b,c
RELEASE PELLETS
in
which
the
drug
is
enclosed
within
either
a
hard
or
soft
soluble
container
or
made
from
a
suitable
form
of
gelatin;
the drug itself
is
in
the
form
of
granules
to
which
enteric
coating
has
been
applied,
thus
delaying
release
of
the
drug
until
its
passage
into
the
intestines.
CAPSULE,
EXTENDED
RELEASE
A
solid
dosage
form
a,b,c
in
which
the
drug
is
enclosed
within
either
a
hard
or
soft
soluble
container
made from a suitable
form
of
gelatin,
and
which releases a drug
(or
drugs)
in
such
a
manner
to
allow
a
reduction
in
dosing
frequency
as
compared
to
that
drug
(or
drugs)
presented
as
a
conventional
dosage
form.
CAP
PELLETS
DR
621
C42904
CAP ER
610
C42916
CAPSULE,
COATED,
EXTENDED
RELEASE
FILM
A
solid
dosage
form
a
in
which
the
drug
is
enclosed
within
either
a
hard
or
soft
soluble
container
or
made
from
a
suitable
form
of
gelatin;
additionally,
the capsule is
covered
in
a
designated
film
coating,
and
which
releases
a
drug
(or
drugs)
in
such
a
manner
to
allow
at
least
a
reduction
in
dosing
frequency
as
compared
to
that
drug
(or
drugs)
presented
as
a
conventional
dosage
form.
CAP
FILM
612
COATED
ER
C42928
CAPSULE,
GELATIN
A
solid
dosage
form
a,b
COATED
in
which
the
drug
is
enclosed
within
either
a
hard
or
soft
soluble
container
made from a
suitable
form
of
gelatin;
through
a
banding
process,
the
capsule
is
coated
with
additional
layers
of
gelatin
so as to form a
complete seal.
CAPSULE,
LIQUID
A
solid
dosage
form
a,b
FILLED
in
which
the
drug
is
enclosed
within
a
soluble,
gelatin
shell
which is plasticized by
the
addition
of
a
polyol,
such
as
sorbitol
or
glycerin,
and
is
therefore
of
a
CAP
GELATIN
605
COATED
C42936
CAP
FILLED
LIQ
606
C42954
somewhat
thicker
consistency
than
that
of
a
hard
shell
capsule;
typically,
the
active ingredients are
dissolved
or
suspended
in
a
liquid
vehicle.
CEMENT
A
substance
that
a
serves
to
produce
solid
union
between
two surfaces.
A
narrow
tube
of
cut
a,b
tobacco
(or
other
similar
material)
enclosed in paper and
designed for smoking.
A
large
piece
of
a,b,c
relatively
flat,
absorbent
material
that
contains
a
drug.
It is typically used for
applying
medication
or for cleansing.
A
liquid
preparation
a,b,c
of
increased
strength
and
reduced
volume
which
is
usually
diluted
prior
to
administration.
A
solid
dosage
form
a,b
bounded by a circular
base
and
the
surface
formed
by
line
segments
joining
every
point
of
the
boundary of the base
to
a
common
vertex.
A
cone
(usually
containing
antibiotics)
is
normally
placed
CEMENT
252
C45414
CIGARETTE
CIGARETTE
253
C42678
CLOTH
CLOTH
845
C60884
CONCENTRATE
CONC
280
C60891
CONE
CONE
049
C42900
below
the
gingiva
after
a
dental
extraction.
CORE,
EXTENDED
An
ocular
system
a,b
RELEASE
placed
in
the
eye
from
which
the
drug
diffuses
through
a
membrane
at
a
constant
rate
over
a
specified
period.
CREAM
An
emulsion,
a,b,c
semisolid
3
dosage
form,
usually
containing
>
20%
water
and
volatiles5
and/or
<
50%
hydrocarbons,
waxes,
or
polyols
as
the
vehicle.
This
dosage
form
is
generally
for
external
application
to the skin or mucous
membranes.
A cream dosage
form
a,b,c
that
enhances
drug
delivery.
Augmentation
does
not
refer
to
the
strength
of
the
drug
in
the
dosage
form.
NOTE:
CDER
has
decided
to
refrain
from
expanding
the
use
of
this
dosage
form
due
to
difficulties
in
setting
specific
criteria
that
must
be
met
to
be
considered
A
naturally
produced
a
angular
solid
of
CORE ER
804
C42919
CREAM
805
C28944
CREAM,
AUGMENTED
CREAM AUG
365
C60897
CRYSTAL
CRYSTAL
051
C42901
definite form in which
the
ultimate
units
from
which
it
is
built
up
are
systematically
arranged;
they
are
usually evenly spaced
on
a
regular
space
lattice.
CULTURE
The
propagation
of
a
microorganisms
or
of
living
tissue
sells
in
special
media
conducive
to
their
growth.
A
device
usually
a
dome-shaped,
worn
during
copulation
over
the
cervical
mouth for prevention
of
conception
or
infection.
A
circular
plate-like
a,b,c
organ or structure.
A
liquid
preparation,
a
intended
for
the
irrigative
cleansing
of
the
vagina,
that
is
prepared
from
powders,
liquid
solutions,
or
liquid
concentrates
and
contains one or more
chemical
substances
dissolved in a suitable
solvent
or
mutually
miscible solvents.
The
application
of
a,b,c
various
materials
for
protecting a wound.
CULTURE
281
C45415
DIAPHRAGM
DIAPHRAGM
255
C47890
DISC
DOUCHE
DISC
DOUCHE
256
838
C43525
C42679
DRESSING
DRESSING
285
C42763
DRUG
DELIVERY
Modern
technology,
a
SYSTEM
distributed with or
as
DDS
259
C17423
a
part
of
a
drug
product
that
allows
for
the
uniform
release
or
targeting
of drugs to the
body.
ELIXIR
A
clear,
pleasantly
a,b,c
flavored,
sweetened
hydroalcoholic
liquid
containing
dissolved
medicinal agents;
it is
intended for oral use.
A
dosage
form
a,b,c
consisting
of
a
two-phase
system
comprised
of
at
least
two
immiscible
liquids
1
, one of
which
is
dispersed
as
droplets
(internal
or
dispersed
phase)
within
the
other
liquid
(external
or
continuous
phase),
generally
stabilized
with
one
or
more
emulsifying
agents.
(Note:
Emulsion
is
used
as
a
dosage
form
term
unless
a
more
specific
term
is
applicable,
e.g.
cream,
lotion,
ointment.)
A
rectal
preparation
a,b,c
for
therapeutic,
diagnostic,
or
nutritive purposes.
A
concentrated
a,b
preparation
of
vegetable
or
animal
drugs
obtained
by
removal
of
the
active
ELIXIR
807
C42912
EMULSION
EMULSION
052
C42913
ENEMA
ENEMA
286
C42915
EXTRACT
EXTRACT
287
C42929
constituents
of
the
respective
drugs
with
a
suitable
menstrua,
evaporation
of
all
or
nearly
all
of
the
solvent,
and
adjustment
of
the
residual
masses
or
powders
to
the
prescribed standards.
FIBER,
EXTENDED
A
slender
and
a,b,c
RELEASE
elongated
solid
thread-like
substance
that
delivers
drug
in
such
a
manner
to
allow
a
reduction
in
dosing
frequency
as
compared
to
that
drug
(or
drugs)
presented
as
a
conventional
dosage
form.
FILM
A
thin
coating.
layer
or
a,b
FIBER ER
847
C60926
FILM
FILM
ER
061
810
C42932
C42920
FILM,
EXTENDED
A
drug
delivery
a,b,c
RELEASE
system in the form
of
a
film
that
releases
the
drug
over
an
extended
period
in
such
a
way
as
to
maintain
constant
drug
levels
in
the
blood or target tissue.
FILM, SOLUBLE
A thin layer
or coating
a,b
which
is
susceptible
to
being
dissolved
when
in
contact
with
a liquid.
A
product,
usually
a
a,c
solid,
intended
for
solution
prior
to
administration.
FILM
SOLUBLE
063
C42984
FOR SOLUTION
FOR SOL
848
C60927
FOR SUSPENSION
A
product,
usually
a
a,c
solid,
intended
for
suspension
prior
to
administration.
FOR SUSP
849
C60928
FOR
SUSPENSION,
A
product,
usually
a
a,c
EXTENDED
solid,
intended
for
RELEASE
suspension
prior
to
administration;
once
the
suspension
is
administered,
the
drug
will
be
released
at
a
constant
rate
over
a
specified
period.
GAS
Any
elastic
aeriform
a,b,c
fluid
in
which
the
molecules
are
separated
from
one
another
and
so
have
free
paths.
A
semisolid
3
dosage
a,b,c
form
that
contains
a
gelling
agent
to
provide
stiffness
to
a
solution or
a colloidal
dispersion.
4
A
gel may
contain
suspended
particles.
A
combination
of
a
a,b
dentifrice
(formulation
intended
to
clean
and/or
polish
the
teeth,
and which may
contain
certain
additional
agents),
and
a
gel.
It
is
used
with a toothbrush for
the
purpose
of
cleaning
and
polishing the teeth.
A
gel
preparation,
a,b,c
FOR SUSP ER
850
C60929
GAS
064
C42933
GEL
GEL
066
C42934
GEL, DENTIFRICE
GEL DENT
806
C42906
GEL,
METERED
GEL MET
851
C60930
with
metered
dose
valves,
which
allow
for
the
delivery
of
a
uniform
quantity
of
gel
upon
each
activation.
GENERATOR
An
apparatus
for
the
a,b
formation of vapor or
gas
from
a
liquid
or
solid
by
heat
or
chemical
action.
The
term
GENERATOR
also
applies
to
radioactive
columns
from
which
radionuclides
are
provided.
Also
called
pellets
or
a,b
pilules,
are
made
of
pure
sucrose, lactose,
or
other
polysaccharides. They
are
formed into small
globular
masses
of
various
sizes,
and
are
medicated
by
placing
them
in
a
vial
and
adding the liquid drug
attenuation
in
the
proportion
not
less
than
one
percent
(v/w).
After
shaking,
the
medicated
globules
are
dried
at
temperatures
not
to
exceed
40
degrees
Centigrade.
A
slip
of
skin
or
of
a,b
other
tissue
for
implantation.
A
small
particle
or
a,b,c
grain.
GENERATOR
289
C48193
GLOBULE
GLOBULE
808
C42937
GRAFT
GRAFT
290
C45416
GRANULE
GRAN
078
C42938
GRANULE,
A
small
medicinal
a,c
DELAYED RELEASE
particle
or
grain
to
which
an
enteric
or
other
coating
has
been
applied,
thus
delaying
release
of
the
drug
until
its
passage
into
the
intestines.
GRANULE,
EFFERVESCENT
A
small
particle
or
a,b,c
grain
containing
a
medicinal
agent
in
a
dry
mixture
usually
composed
of
sodium
bicarbonate,
citric
acid, and tartaric
acid
which,
when
in
contact
with
water,
has
the
capability
to
release
gas,
resulting
in effervescence.
GRAN DR
820
C42903
GRAN EFFRV
080
C42909
GRANULE,
SOLUTION
FOR
A
small
medicinal
a,b
particle or grain made
available
in
its
more
stable dry form, to be
reconstituted
with
solvent
just
before
dispensing;
the
granules
are
so
prepared
to
contain
not
only
the
medicinal
agent,
but
the
colorants,
flavorants,
and
any
other
desired
pharmaceutic
ingredient.
GRAN F/SOL
809
C42939
GRANULE,
FOR
A
small
medicinal
a,b
SUSPENSION
particle or grain made
available
in
its
more
stable dry form, to be
reconstituted
with
solvent
just
before
GRAN F/SUSP
819
C42940
dispensing
to
form
a
suspension;
the
granules
are
so
prepared
to
contain
not
only
the
medicinal
agent,
but
the
colorants,
flavorants,
and
any
other
desired
pharmaceutic
ingredient.
GRANULE,
FOR
A
small
medicinal
a
SUSPENSION,
particle or
grain made
EXTENDED
available
in
its
more
RELEASE
stable dry form, to be
reconstituted
with
solvent
just
before
dispensing
to
form
a
suspension;
the
extended
release
system
achieves
slow
release
of
the
drug
over
an
extended
period
of
time
and
maintains
constant
drug
levels
in
the
blood or target tissue.
GUM
A
mucilaginous
a,b
excretion
from
various plants.
A
sweetened
and
a,b,c
flavored
insoluble
plastic
material
of
various
shapes
which
when
chewed,
releases
a
drug
substance
into
the
oral
cavity.
Natural
mixture
of
a,b
gum
and
resin,
usually
obtained
as
exudations
from
GRAN
F/SUSP
811
ER
C42921
GUM
084
C42941
GUM, CHEWING
GUM
CHEWING
085
C42894
GUM, RESIN
GUM RESIN
087
C42978
plants.
IMPLANT
A
material
containing
a,b,c
drug
intended
to
be
inserted
securely
of
deeply
in
a
living
site
for
growth,
slow
release,
or
formation
of an organic
union.
A
special
class
of
a,b,c
inhalations
consisting
of
a
drug
or
combination of drugs,
that by virtue of their
high
vapor
pressure
can
be
carried
by
an
air
current
into
the
nasal
passage
where
they
exert
their
effect;
the
container
from
which
the
inhalant
generally
is
administered
is
known as an inhaler.
An
injection,
which
a,c
either
consists
of
or
forms
liposomes
(a
lipid
bilayer
vesicle
usually
composed
of
phospholipids
which
is
used
to
encapsulate an active
drug
substance).
A
sterile
preparation
a,b
intended
for
parenteral
use;
five
distinct
classes
of
injections
exist
as
defined by the
USP
.
An
emulsion
a,b
consisting of a sterile,
pyrogen-free
preparation
intended
IMP
715
C42942
INHALANT
INHALANT
293
C42944
INJECTABLE,
LIPOSOMAL
INJ LIPOS
852
C60931
INJECTION
INJ
700
C42946
INJECTION,
EMULSION
INJ
EMULSION
701
C42914
to
be
administered
parenterally.
INJECTION,
LIPID
[definition pending]
COMPLEX
INJECTION,
POWDER,
SOLUTION
a
INJ
LIPID
716
COMPLEX
INJ
F/SOL
PWD
702
C42950
C42974
A
sterile
preparation
a,b
FOR
intended
for
reconstitution
to
form
a
solution
for
parenteral use.
INJECTION,
A
sterile
preparation
a,b
POWDER,
FOR
intended
for
SUSPENSION
reconstitution
to
form a suspension for
parenteral use.
INJECTION,
A
dried
preparation
a,b
POWDER,
FOR
intended
for
SUSPENSION,
reconstitution
to
EXTENDED
form
a suspension for
RELEASE
parenteral
use
which
has
been
formulated
in
a
manner
to
allow
at least a reduction in
dosing
frequency
as
compared
to
that
drug
presented
as
a
conventional
dosage
form
(e.g.,
as
a
solution).
INJECTION,
A
sterile
freeze
dried
a,b
POWDER,
preparation
intended
LYOPHILIZED,
FOR
for
reconstitution
for
LIPOSOMAL
parenteral
use
which
SUSPENSION
has
been
formulated
in
a
manner
that
would
allow
liposomes
(a
lipid
bilayer
vesicle usually
composed
of
phospholipids
which
is
used
to
encapsulate an active
drug
substance,
INJ
PWD
703
F/SUSP
C42976
INJ
PWD
710
F/SUSP ER
C42977
INJ
PWD
LYO
713
F/LS
C42959
either
within
a
lipid
bilayer
or
in
an
aqueous space) to be
formed
upon
reconstitution.
INJECTION,
A
dosage
form
a,b
POWDER,
intended
for
the
LYOPHILIZED,
FOR
solution
prepared
by
SOLUTION
lyophilization
(
drying
a
process
which
involves
the
removal
of
water
from
products
in
the
frozen
state
at
extremely
low
pressures;
this
is
intended
for
subsequent
addition
of
liquid
to
create
a
solution
that
conforms
in
all
respects
to
the
requirements
for
Injections.
INJECTION,
A
liquid
preparation,
a,b
POWDER,
intended
for
LYOPHILIZED,
FOR
parenteral
use
that
SUSPENSION
contains
solids
suspended
in
a
suitable fluid medium
and
conforms
in
all
respects
to
the
requirements
for
Sterile
Suspensions;
the
medicinal
agents
intended
for
the
suspension
are
prepared
by
lyophilization
(
drying
a
process
which
involves
the
removal
of
water
from
products
in
the
INJ
PWD
LYO
705
F/SOL
C42957
INJ
PWD
LYO
706
F/SUSP
C42958
frozen
state
at
extremely
low
pressures.
INJECTION,
A
sterile
freeze
dried
a,b
POWDER,
preparation
intended
LYOPHILIZED,
FOR
for
reconstitution
for
SUSPENSION,
parenteral
use
which
EXTENDED
has
been
formulated
RELEASE
in
a
manner
to
allow
at least
a reduction in
dosing
frequency
as
compared
to
that
drug
presented
as
a
conventional
dosage
form
(e.g.,
as
a
solution).
INJECTION,
SOLUTION
A
liquid
preparation
a,b
containing
one
or
more drug substances
dissolved in a suitable
solvent
or
mixture
of
mutually
miscible
solvents
that
is
suitable for injection.
A
sterile
preparation
a,b
for
parenteral
use
which,
upon
the
addition
of
suitable
solvents,
yields
a
solution
conforming
in
all
respects
to
the
requirements
for
Injections.
A
liquid
preparation,
a,b
suitable
for
injection,
which
consists
of
solid
particles
dispersed
throughout
a
liquid
phase
in
which
the
particles
are not soluble.
It can
also
consist
of
an
oil
INJ
PWD
LYO
712
F/SUSPER
C42956
INJ SOL
708
C42945
INJECTION,
SOLUTION,
CONCENTRATE
INJ SOL CONC
709
C42899
INJECTION,
SUSPENSION
INJ SUSP
704
C42995
phase
dispersed
throughout
an
aqueous
phase,
or
vice-versa.
INJECTION,
SUSPENSION,
EXTENDED
RELEASE
A
sterile
preparation
a,b
intended
for
parenteral
use
which
has
been
formulated
in
a
manner
to
allow
at least a reduction in
dosing
frequency
as
compared
to
that
drug
presented
as
a
conventional
dosage
form
(e.g.,
as
a
solution
or
a
prompt
drug-
releasing,
conventional
solid
dosage form).
A
liquid
preparation,
a,b
suitable
for
injection,
which
consists
of
an
oil
phase
dispersed
throughout
an
aqueous
phase
in
such
a
manner
that
liposomes
(a
lipid
bilayer vesicle
usually
composed
of
phospholipids
which
is
used
to
encapsulate an active
drug
substance,
either
within
a
lipid
bilayer
or
in
an
aqueous
space)
are
formed.
A
liquid
preparation,
a
suitable
for
injection,
which
consists
of
solid
particles
dispersed
throughout
a
liquid
phase
in
INJ SUSP ER
711
C42926
INJECTION,
SUSPENSION,
LIPOSOMAL
INJ
LIPOS
SUSP
714
C42951
INJECTION,
SUSPENSION,
SONICATED
INJ SUSP SON
840
C42988