NDC 0409-3508

Imipenem and Cilastatin

Imipenem And Cilastatin

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

• Product ID: 0409-3508_ad96cecb-40e9-4197-809d-0788fe641543
• NDC: 0409-3508
• Product Type: Human Prescription Drug
• Proprietary Name: Imipenem and Cilastatin
• Generic Name: Imipenem And Cilastatin
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-11-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090825
• Labeler Name: Hospira, Inc.
• Substance Name: IMIPENEM; CILASTATIN SODIUM
• Active Ingredient Strength: 250 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 0409-3508-01

25 VIAL, SINGLE-DOSE in 1 CARTON (0409-3508-01) > 100 mL in 1 VIAL, SINGLE-DOSE (0409-3508-21)

• Marketing Start Date: 2011-11-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-3508-01 [00409350801]

Imipenem and Cilastatin INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090825
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-11-16
• Marketing End Date: 2017-07-31

NDC 0409-3508-21 [00409350821]

Imipenem and Cilastatin INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090825
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-19
• Marketing End Date: 2017-07-31

NDC 0409-3508-22 [00409350822]

Imipenem and Cilastatin INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090825
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-11-17
• Marketing End Date: 2015-05-31

NDC 0409-3508-10 [00409350810]

Imipenem and Cilastatin INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090825
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-11-17
• Marketing End Date: 2015-05-31

Drug Details

Active Ingredients

Ingredient	Strength
IMIPENEM	250 mg/100mL

OpenFDA Data

• SPL SET ID: fe44d24d-55cd-439c-895b-00a38cd59f65
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • 71OTZ9ZE0A
  • 5428WXZ74M
• RxNorm Concept Unique ID - RxCUI:
  • 1726214
  • 1726204

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"

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