Drg00907

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

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.

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.

NAME	DEFINITION	FDA CODE	NCI CONCEPT ID
AMPULE	A container capable of being hermetically sealed, intended to hold sterile materials.	AMP	C43165
APPLICATOR	A pre‑filled non‑injectable pipette, syringe or tube.	AP	C43166
BAG	A sac or pouch.	BAG	C43167
BLISTER PACK	A 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.	BLPK	C43168
BOTTLE	A vessel with a narrow neck designed to accept a specific closure.	BOT	C43169
BOTTLE, WITH APPLICATOR	A bottle which includes a device for applying its contents.	BOTAP	C43177
BOTTLE, DISPENSING	A bottle that is used by the pharmacist to dispense the prescribed medication. It includes preparations for which a dropper accompanies the bottle.	BOTDIS	C43170
BOTTLE, DROPPER	A 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).	BOTDR	C43171
BOTTLE, GLASS	A glass vessel with a narrow neck designed to accept a specific closure.	BOTGL	C43172
BOTTLE, PLASTIC	A plastic vessel with a narrow neck designed to accept a specific closure.	BOTPL	C43173
BOTTLE, PUMP	A bottle that is fitted with a pumping mechanism for the administration of drug product.	BOTPU	C43174
BOTTLE, SPRAY	A bottle that is fitted with an atomizer or a device which produces finely divided liquid carried by air.	BOTSPR	C43175
BOTTLE, UNIT-DOSE	A bottle that contains a single whole dose of a non-parenteral drug product.	BOTUD	C43176
BOX	A square or rectangular vessel, usually made of cardboard or plastic.	BOX	C43178
BOX, UNIT-DOSE	A 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.]	BOXUD	C43179
CAN	A cylindrical vessel, usually made of metal.	CAN	C43180
CANISTER	A type of can for holding a drug product.	CSTR	C43181
CARTON	A cardboard box or container which is usually considered a secondary packaging component.	CRTN	C43182
CARTRIDGE	A 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.	CTG	C43183
CASE	A receptacle for holding something (e.g., that into which some oral contraceptive blister packs are placed).	CASE	C43184
CELLO PACK	A plastic "clamshell" [thin plastic pre‑formed structure for a device].	CELLO	C43185
CONTAINER	A receptacle designed to hold a specific dosage form.	CTR	C43186
CUP	A bowl-shaped container.	CUP	C43187
CUP, UNIT-DOSE	A cup intended to hold a single dose of a non-parenteral drug product.	CUPUD	C43188
CYLINDER	A container designed specifically to hold gases.	CYL	C43189
DEWAR	A 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”).	DEW	C43190
DIALPACK	A 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.	DLPK	C43191
DOSE PACK	A container in which a preselected dose or dose regimen of the medication is placed.	DSPK	C43192
DRUM	A straight‑sided cylindrical shipping container with flat ends; one of which can be opened/closed.	DRUM	C43193
INHALER	A device by means of which a medicinal product can be administered by inspiration through the nose or the mouth.	INHL	C16738
INHALER, REFILL	A container of medication intended to refill an inhaler.	INHLRE	C43194
JAR	A rigid container having a wide mouth and often no neck which typically holds solid or semisolid drug products.	JAR	C43195
JUG	A large, deep container that has a narrow mouth, is typically fitted with a handle, and is used to hold liquids.	JUG	C43196
KIT	A package which includes a container of drug product(s) and the equipment and supplies used with it.	KIT	C43197
NOT STATED	The package type is not stated or is unavailable.	NS	C48626
PACKAGE	The drug product container with any accompanying materials or components. This may include the protective packaging, labeling, administration devices, etc.	PKG	C43233
PACKAGE, COMBINATION	A package in which two or more drug products that are normally available separately are now available together.	PKGCOM	C43198
PACKET	An 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.	PKT	C43199
POUCH	A 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).	POU	C43200
SUPERSACK	A multilayer paper bag for shipping some solid bulk excipients, usually in the form of powder or granules.	SUPSACK	C43201
SYRINGE	A 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.	SYR	C43202
SYRINGE, GLASS	A 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.	SYRGL	C43203
SYRINGE, PLASTIC	A 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.	SYRPL	C43204
TABMINDER	A specialized package; it registers each time it is opened and is used for checking patient compliance to prescribed medication regimens.	TABMIND	C43205
TANK	A large receptacle used for holding, transporting, or storing liquids or gases, and often referred to as a reservoir.	TANK	C43206
TRAY	A 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.	TRAY	C53438
TUBE	A flexible container for semisolid drug products which is flattened and crimped or sealed at one end and has a reclosable opening at the other.	TUBE	C42794
TUBE, WITH APPLICATOR	A 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.	TUBEAP	C43207
VIAL	A container designed for use with parenteral drug products.	VIAL	C43226
VIAL, DISPENSING	A vial that is used by the pharmacist to dispense the prescribed medication.	VIALDIS	C43208
VIAL, GLASS	A glass container designed for use with parenteral drug products.	VIALGL	C43209
VIAL, MULTI-DOSE	A vial intended to contain more than one dose of the drug product.	VIALMD	C43210
VIAL, PATENT DELIVERY SYSTEM	A vial that has a patented delivery system.	VIALPAT	C43211
VIAL, PHARMACY BULK PACKAGE	A 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.	VIALPHR	C43212
VIAL, PIGGYBACK	A vial that contains a parenteral preparation that can be attached directly to the tubing of a parenterally administered fluid.	VIALPIG	C43213
VIAL, PLASTIC	A plastic container designed for use with parenteral drug products.	VIALPL	C43214
VIAL, SINGLE-DOSE	A vial containing a single unit of a parenteral drug product.	VIALSD	C43215
VIAL, SINGLE-USE	A vial where a single dose of a parenteral drug product can be removed, and then the vial and its remaining contents can be disposed.	VIALSU	C43216

CDER DATA STANDARDS MANUAL