Imipenem and Cilastatin
These highlights do not include all the information needed to use Imipenem and Cilastatin for Injection, USP (I.V.) safely and effectively. See full prescribing information for Imipenem and Cilastatin for Injection, USP (I.V.). IMIPENEM AND CILASTATIN FOR INJECTION, USP, for intravenous use Initial U.S. Approval: 1985
Approved
Approval ID
0a1dd9b9-ada1-4bff-9dcb-18961254e9e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Imipenem and Cilastatin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-349
Application NumberANDA090577
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipenem and Cilastatin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2020
FDA Product Classification
INGREDIENTS (3)
SODIUM BICARBONATEInactive
Quantity: 10 mg in 20 mL
Code: 8MDF5V39QO
Classification: IACT
IMIPENEMActive
Quantity: 250 mg in 20 mL
Code: 71OTZ9ZE0A
Classification: ACTIM
CILASTATIN SODIUMActive
Quantity: 250 mg in 20 mL
Code: 5428WXZ74M
Classification: ACTIM
Imipenem and Cilastatin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-322
Application NumberANDA090577
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipenem and Cilastatin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2020
FDA Product Classification
INGREDIENTS (3)
SODIUM BICARBONATEInactive
Quantity: 20 mg in 20 mL
Code: 8MDF5V39QO
Classification: IACT
IMIPENEMActive
Quantity: 500 mg in 20 mL
Code: 71OTZ9ZE0A
Classification: ACTIM
CILASTATIN SODIUMActive
Quantity: 500 mg in 20 mL
Code: 5428WXZ74M
Classification: ACTIM