NDC 0006-3516

PRIMAXIN IV

Imipenem And Cilastatin Sodium

PRIMAXIN IV is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Imipenem; Cilastatin Sodium.

• Product ID: 0006-3516_25896be0-b49d-43cd-8f90-105327b2ecfe
• NDC: 0006-3516
• Product Type: Human Prescription Drug
• Proprietary Name: PRIMAXIN IV
• Generic Name: Imipenem And Cilastatin Sodium
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1985-11-26
• Marketing Category: NDA / NDA
• Application Number: NDA050587
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: IMIPENEM; CILASTATIN SODIUM
• Active Ingredient Strength: 500 mg/100mL; mg/100mL
• Pharm Classes: Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0006-3516-59

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

• Marketing Start Date: 1985-11-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-3516-59 [00006351659]

PRIMAXIN IV INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA050587
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1985-11-26

Drug Details

Active Ingredients

Ingredient	Strength
IMIPENEM	500 mg/100mL

OpenFDA Data

• SPL SET ID: f41d8abd-7792-4918-1b93-bd83ea01955e
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • 5428WXZ74M
  • 71OTZ9ZE0A
• RxNorm Concept Unique ID - RxCUI:
  • 1726216
  • 1726214
  • 1726204
  • 1726207

Pharmacological Class

• Carbapenems [CS]
• Penem Antibacterial [EPC]
• Dipeptidase Inhibitors [MoA]
• Renal Dehydropeptidase Inhibitor [EPC]

NDC Crossover Matching brand name "PRIMAXIN IV" or generic name "Imipenem And Cilastatin Sodium"

NDC	Brand Name	Generic Name
63323-322	Imipenem and Cilastatin	Imipenem and Cilastatin Sodium
63323-349	Imipenem and Cilastatin	Imipenem and Cilastatin Sodium
0006-3516	PRIMAXIN	imipenem and cilastatin sodium