primaxin iv

Generic: imipenem and cilastatin sodium

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name primaxin iv
Generic Name imipenem and cilastatin sodium
Labeler merck sharp & dohme llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cilastatin sodium 500 mg/100mL, imipenem 500 mg/100mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-3516
Product ID 0006-3516_34854f9b-7be0-4bfb-8cd2-40baf206fb80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050587
Listing Expiration 2026-12-31
Marketing Start 1985-11-26

Pharmacologic Class

Classes
carbapenems [cs] dipeptidase inhibitors [moa] penem antibacterial [epc] renal dehydropeptidase inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00063516
Hyphenated Format 0006-3516

Supplemental Identifiers

RxCUI
1726204 1726207 1726214 1726216
UPC
0300063516594
UNII
5428WXZ74M 71OTZ9ZE0A

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name primaxin iv (source: ndc)
Generic Name imipenem and cilastatin sodium (source: ndc)
Application Number NDA050587 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/100mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0006-3516-59 25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

cilastatin sodium (500 mg/100mL) imipenem (500 mg/100mL)

Linked Drug Pages (1)

PRIMAXIN IV ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "34854f9b-7be0-4bfb-8cd2-40baf206fb80", "openfda": {"upc": ["0300063516594"], "unii": ["5428WXZ74M", "71OTZ9ZE0A"], "rxcui": ["1726204", "1726207", "1726214", "1726216"], "spl_set_id": ["f41d8abd-7792-4918-1b93-bd83ea01955e"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59)  / 100 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0006-3516-59", "marketing_start_date": "19851126"}], "brand_name": "PRIMAXIN IV", "product_id": "0006-3516_34854f9b-7be0-4bfb-8cd2-40baf206fb80", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Dipeptidase Inhibitors [MoA]", "Penem Antibacterial [EPC]", "Renal Dehydropeptidase Inhibitor [EPC]"], "product_ndc": "0006-3516", "generic_name": "imipenem and cilastatin sodium", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRIMAXIN", "brand_name_suffix": "IV", "active_ingredients": [{"name": "CILASTATIN SODIUM", "strength": "500 mg/100mL"}, {"name": "IMIPENEM", "strength": "500 mg/100mL"}], "application_number": "NDA050587", "marketing_category": "NDA", "marketing_start_date": "19851126", "listing_expiration_date": "20261231"}