Drug Information

Product NDC: 0006-3516

Proprietary Name: PRIMAXIN

Non Proprietary Name: imipenem and cilastatin sodium

Active Ingredient(s):
  • 500 mg/100mL IMIPENEM;
  • 500 mg/100mL CILASTATIN SODIUM

Administration Route(s): INTRAVENOUS


Pharmacy Class(es):
  • Carbapenems [CS];
  • Penem Antibacterial [EPC];
  • Dipeptidase Inhibitors [MoA];
  • Renal Dehydropeptidase Inhibitor [EPC]

Labeler Information

Labeler Name: Merck Sharp & Dohme Corp.
FDA Application Number: NDA050587
Marketing Category: NDA
Start Marketing Date:11/26/1985

Package Information

No. Package Code Package Description Billing Unit
10006-3516-5925 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) > 100 mL in 1 VIAL, SINGLE-DOSEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0006-3516The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEPRIMAXINThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXIVA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEimipenem and cilastatin sodiumThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, POWDER, FOR SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE11/26/1985This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA050587This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEMerck Sharp & Dohme Corp.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIMIPENEM; CILASTATIN SODIUMThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE INGRED UNITmg/100mL; mg/100mL 
PHARM CLASSESCarbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 

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This page was last updated on: 6/12/2020