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.
| 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 |