Home NDC 0006-3516 PRIMAXIN
Product NDC 0006-3516
11-digit product format 000063516
Labeler code 0006
Product ID 0006-3516_34854f9b-7be0-4bfb-8cd2-40baf206fb80
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name imipenem and cilastatin sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Merck Sharp & Dohme LLC
Application NDA050587
Marketing category NDA
Marketing start 1985-11-26
Substance CILASTATIN SODIUM; IMIPENEM
Active strength 500; 500 mg/100mL; mg/100mL
Pharmacologic classes Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050587-001 PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 1985-11-26 N050587-002 PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 1985-11-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050587-002 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N050587-001 PRIMAXIN EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 1985-11-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N050587-002 PRIMAXIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 1985-11-26 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N050587-002 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PRIMAXIN
Brand name suffix IV
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IMIPENEM 500 mg/100mL CILASTATIN SODIUM 500 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 71OTZ9ZE0A Internal UNII lookup 5428WXZ74M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726204 Internal RxNorm lookup 1726207 Internal RxNorm lookup 1726214 Internal RxNorm lookup 1726216 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-3516-59 PRIMAXINIV 25 in 1 TRAY INJECTION, POWDER, FOR SOLUTION 25 34 0006-3516-59 PRIMAXINIV 100 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, FOR SOLUTION 100 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CILASTATIN SODIUM ACTIVE INGREDIENT 5428WXZ74M PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 16 IMIPENEM ACTIVE INGREDIENT 71OTZ9ZE0A PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 16 CILASTATIN ACTIVE MOIETY 141A6AMN38 PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 16 IMIPENEM ANHYDROUS ACTIVE MOIETY Q20IM7HE75 PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 16 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-3516 PRIMAXIN IV (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME LLC] 33 Current NDC, Legacy NDC, 2 package rows 20240713_f41d8abd-7792-4918-1b93-bd83ea01955e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0006-3516-59 00006351659 25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSE 1985-11-26 0000-00-00 No No Current