NDC 63323-349

Imipenem and Cilastatin

Imipenem And Cilastatin Sodium

Imipenem and Cilastatin is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Imipenem; Cilastatin Sodium.

• Product ID: 63323-349_20a2a1c8-4736-449f-8d03-8472e1408baf
• NDC: 63323-349
• Product Type: Human Prescription Drug
• Proprietary Name: Imipenem and Cilastatin
• Generic Name: Imipenem And Cilastatin Sodium
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-01-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090577
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: IMIPENEM; CILASTATIN SODIUM
• Active Ingredient Strength: 250 mg/20mL; mg/20mL
• Pharm Classes: Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63323-349-25

25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-25) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-01)

• Marketing Start Date: 2012-01-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-349-93 [63323034993]

Imipenem and Cilastatin INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090577
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-01-03

NDC 63323-349-20 [63323034920]

Imipenem and Cilastatin INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090577
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-01-03
• Marketing End Date: 2018-04-27

NDC 63323-349-25 [63323034925]

Imipenem and Cilastatin INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090577
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-01-03

NDC 63323-349-94 [63323034994]

Imipenem and Cilastatin INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090577
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-01-03

Drug Details

Active Ingredients

Ingredient	Strength
IMIPENEM	250 mg/20mL

OpenFDA Data

• SPL SET ID: 6ab0ca9e-9a79-4cab-9f09-470eda06952e
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 71OTZ9ZE0A
  • 5428WXZ74M

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0409-3507	Imipenem and Cilastatin	Imipenem and Cilastatin
0409-3508	Imipenem and Cilastatin	Imipenem and Cilastatin
44567-705	Imipenem and Cilastatin	Imipenem and Cilastatin
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