Drugs

Data Standards Manual (monographs) Package Type

FDA Data Element Number. 

CDER Data Element Number.  C-DRG-00907

Data Element Name.  Package Type

Data Element OID: 2.16.840.1.113883.3.26.1.1.3
Data Element NCI Concept ID: C43164

Version Number.  003

Description.  This standard provides for all types of packages that bulk drug substances and final drug dosage forms are contained in, including both the immediate (or primary) and secondary containers.

Source.  Drug registration and Listing System

Relationship.  C-DRG-00201 is for drug dosage forms.

FDA Specifications.  None.

CDER Specifications.  Package Type (abbreviated as DRLS_PKG_TYPE in the MIS reference table) shall consist of an alphabetic term which has a maximum length restricted to 240 characters, with the comma and hyphen being the only punctuation permissible.  FDA Codes representing these package types shall consist of a maximum of eight letters.  SPL shall use the NCI Concept ID as its code.

All package types shall comply with any applicable 21 CFR regulations, CDER guidances, and compendial monographs.  The container is that which holds the article and is or may be in direct contact with the article. The immediate container is that which is in direct contact with the article at all times. The closure is a part of the container.

FDA Approved Date. 

CDER Approved Date.  March 9. 1998

FDA Revised Date. 

CDER Revised Date.  July 26, 1999, January 11, 2006; January 25, 2006

Data Values.  See next page.

NAMEDEFINITIONFDA CODENCI
CONCEPT ID
AMPULEA container capable of being hermetically sealed, intended to hold sterile materials.AMPC43165
APPLICATORA pre‑filled non‑injectable pipette, syringe or tube.APC43166
BAGA sac or pouch.BAGC43167
BLISTER PACKA package that consists of molded plastic or laminate that has indentations (viewed as “blisters” when flipped) into which a dosage form, is placed.  A covering, usually of  laminated material, is then sealed to the molded part.  A strip pack is a specialized type of blister pack where there are no pre-formed or molded parts; in this case there are two flexible layers that are sealed with the dosage form in between.  Suppositories that are strip packed between two layers of foil are also considered a blister pack.BLPKC43168
BOTTLEA vessel with a narrow neck designed to accept a specific closure.BOTC43169
BOTTLE, WITH APPLICATORA bottle which includes a device for applying its contents.BOTAPC43177
BOTTLE, DISPENSINGA bottle that is used by the pharmacist to dispense the prescribed medication.  It includes preparations for which a dropper accompanies the bottle.BOTDISC43170
BOTTLE, DROPPERA bottle that has a device specifically intended for the application of a liquid in a drop by drop manner, or a device intended for the delivery of an exact dose (e.g., calibrated dropper for oral medications).BOTDRC43171
BOTTLE, GLASSA glass vessel with a narrow neck designed to accept a specific closure.BOTGLC43172
BOTTLE, PLASTICA plastic vessel with a narrow neck designed to accept a specific closure.BOTPLC43173
BOTTLE, PUMPA bottle that is fitted with a pumping mechanism for the administration of drug product.BOTPUC43174
BOTTLE, SPRAYA bottle that is fitted with an atomizer or a device which produces finely divided liquid carried by air.BOTSPRC43175
BOTTLE, UNIT-DOSEA bottle that contains a single whole dose of a non-parenteral drug product.BOTUDC43176
BOXA square or rectangular vessel, usually made of cardboard or plastic.BOXC43178
BOX, UNIT-DOSEA box that contains a single dose of a non-parenteral drug product. [Note: Boxes that contain 100 unit dose blister packs should be classified under blister pack, since this is the immediate container into which the dosage form is placed.]BOXUDC43179
CANA cylindrical vessel, usually made of metal.CANC43180
CANISTERA type of can for holding a drug product.CSTRC43181
CARTONA cardboard box or container which is usually considered a secondary packaging component.CRTNC43182
CARTRIDGEA container consisting of a cylinder with a septum at one end, and a seal at the other end, which is inserted into a device to form a syringe which contains a single dose of a parenteral drug product.CTGC43183
CASEA receptacle for holding something (e.g., that into which some oral contraceptive blister packs are placed).CASEC43184
CELLO PACKA plastic "clamshell" [thin plastic pre‑formed structure for a device].CELLOC43185
CONTAINERA receptacle designed to hold a specific dosage form.CTRC43186
CUPA bowl-shaped container.CUPC43187
CUP, UNIT-DOSEA cup intended to hold a single dose of a non-parenteral drug product.CUPUDC43188
CYLINDERA container designed specifically to hold gases.CYLC43189
DEWARA container, usually made of glass or metal, that has at least two walls with the space between each wall evacuated so as to prevent the transfer of heat.  The inside of the container often has a coating (as silvering) on the inside to reduce heat transfer, and is used especially for storing liquified gases or for experiments at low temperatures.  The size can vary from that of a small thermos bottle up to that which may be mounted upon a large truck (also known as a “cryogenic truck”). DEWC43190
DIALPACKA dose pack container designed to assist with patient compliance.  The patient turns a dial to the correct day and the correct dose is made available and the container indicates that the dose has been removed.DLPKC43191
DOSE PACKA container in which a preselected dose or dose regimen of the medication is placed.DSPKC43192
DRUMA straight‑sided cylindrical shipping container with flat ends; one of which can be opened/closed.DRUMC43193
INHALERA device by means of which a medicinal product can be administered by inspiration through the nose or the mouth.INHLC16738
INHALER, REFILLA container of medication intended to refill an inhaler.INHLREC43194
JARA rigid container having a wide mouth and often no neck which typically holds solid or semisolid drug products.JARC43195
JUGA large, deep container that has a narrow mouth, is typically fitted with a handle, and is used to hold liquids.JUGC43196
KITA package which includes a container of drug product(s) and the equipment and supplies used with it.KITC43197
NOT STATEDThe package type is not stated or is unavailable.NSC48626
PACKAGEThe drug product container with any accompanying materials or components.  This may include the protective packaging, labeling, administration devices, etc.PKGC43233
PACKAGE, COMBINATIONA package in which two or more drug products that are normally available separately are now available together.PKGCOMC43198
PACKETAn envelope into which only one dose of a drug product, usually in the form of granules or powder, has been directly placed.  An example includes glassine powder paper containing aspirin.  Other examples include aluminum foil packets into which alcohol swabs and pledgets are placed.PKTC43199
POUCHA flexible container used to protect or hold one or more doses of a drug product (e.g. a pouch into which oral contraceptive blister packs are inserted, and an overwrap pouch for large volume parenterals).POUC43200
SUPERSACKA multilayer paper bag for shipping some solid bulk excipients, usually in the form of powder or granules.SUPSACKC43201
SYRINGEA device for the administration of parenteral drug products that consists of a rigid barrel fitted with septum with a plunger at one end and a seal or needle at the other end.  The needle assembly may be part of the device or separate.SYRC43202
SYRINGE, GLASSA device for the administration of parenteral drug products that consists of a rigid glass barrel fitted with septum with a plunger at one end and a seal or needle at the other end.  The needle assembly may be part of the device or separate.SYRGLC43203
SYRINGE, PLASTICA device for the administration of parenteral drug products that consists of a rigid plastic barrel fitted with septum with a plunger at one end and a seal or needle at the other end.  The needle assembly may be part of the device or separate.SYRPLC43204
TABMINDERA specialized package; it registers each time it is opened and is used for checking patient compliance to prescribed medication regimens.TABMINDC43205
TANKA large receptacle used for holding, transporting, or storing liquids or gases, and often referred to as a reservoir.TANKC43206
TRAYA shallow flat receptacle, with a raised edge or rim, used for carrying, holding, or displaying finished drug product in its primary or market package.  A tray and its contents may be encased in shrink-wrapped plastic for shipping, or with a cover or an overwrap as part of a unit of use package or kit.TRAYC53438
TUBEA flexible container for semisolid drug products which is flattened and crimped or sealed at one end and has a reclosable opening at the other.TUBEC42794
TUBE, WITH APPLICATORA tube which is provided with a device (the applicator) for administering the dosage form.  The applicator may be part of the tube closure or be separate.TUBEAPC43207
VIALA container designed for use with parenteral drug products.VIALC43226
VIAL, DISPENSINGA vial that is used by the pharmacist to dispense the prescribed medication.VIALDISC43208
VIAL, GLASSA glass container designed for use with parenteral drug products.VIALGLC43209
VIAL, MULTI-DOSEA vial intended to contain more than one dose of the drug product.VIALMDC43210
VIAL, PATENT DELIVERY SYSTEMA vial that has a patented delivery system.VIALPATC43211
VIAL, PHARMACY BULK PACKAGEA container of a sterile preparation whose contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes.VIALPHRC43212
VIAL, PIGGYBACKA vial that contains a parenteral preparation that can be attached directly to the tubing of a parenterally administered fluid.VIALPIGC43213
VIAL, PLASTICA plastic container designed for use with parenteral drug products.VIALPLC43214
VIAL, SINGLE-DOSEA vial containing a single unit of a parenteral drug product.VIALSDC43215
VIAL, SINGLE-USEA vial where a single dose of a parenteral drug product can be removed, and then the vial and its remaining contents can be disposed.VIALSUC43216

 

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