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PRIMAXIN

These highlights do not include all the information needed to use PRIMAXIN safely and effectively. See full prescribing information for PRIMAXIN. PRIMAXIN® (imipenem and cilastatin) for Injection, for intravenous useInitial U.S. Approval: 1985

Approved
Approval ID

f41d8abd-7792-4918-1b93-bd83ea01955e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2023

Manufacturers
FDA

Merck Sharp & Dohme LLC

DUNS: 118446553

Products 4

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 Code0006-3516
Application NumberNDA050587
Product Classification
M
Marketing Category
C73594
G
Generic Name
imipenem and cilastatin sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 24, 2022
FDA Product Classification

INGREDIENTS (3)

IMIPENEMActive
Quantity: 500 mg in 100 mL
Code: 71OTZ9ZE0A
Classification: ACTIM
CILASTATIN SODIUMActive
Quantity: 500 mg in 100 mL
Code: 5428WXZ74M
Classification: ACTIM
SODIUM BICARBONATEInactive
Quantity: 20 mg in 100 mL
Code: 8MDF5V39QO
Classification: IACT

imipenem and cilastatin sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0006-3552
Application NumberANDA062756
Product Classification
M
Marketing Category
C73584
G
Generic Name
imipenem and cilastatin sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 24, 2022
FDA Product Classification

INGREDIENTS (3)

IMIPENEMActive
Quantity: 500 mg in 100 mL
Code: 71OTZ9ZE0A
Classification: ACTIM
CILASTATIN SODIUMActive
Quantity: 500 mg in 100 mL
Code: 5428WXZ74M
Classification: ACTIM
SODIUM BICARBONATEInactive
Quantity: 20 mg in 100 mL
Code: 8MDF5V39QO
Classification: IACT

imipenem and cilastatin sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0006-3514
Application NumberNDA050587
Product Classification
M
Marketing Category
C73594
G
Generic Name
imipenem and cilastatin sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 24, 2022
FDA Product Classification

INGREDIENTS (3)

IMIPENEMActive
Quantity: 250 mg in 100 mL
Code: 71OTZ9ZE0A
Classification: ACTIM
CILASTATIN SODIUMActive
Quantity: 250 mg in 100 mL
Code: 5428WXZ74M
Classification: ACTIM
SODIUM BICARBONATEInactive
Quantity: 10 mg in 100 mL
Code: 8MDF5V39QO
Classification: IACT

imipenem and cilastatin sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0006-3551
Application NumberANDA062756
Product Classification
M
Marketing Category
C73584
G
Generic Name
imipenem and cilastatin sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 24, 2022
FDA Product Classification

INGREDIENTS (3)

SODIUM BICARBONATEInactive
Quantity: 10 mg in 100 mL
Code: 8MDF5V39QO
Classification: IACT
IMIPENEMActive
Quantity: 250 mg in 100 mL
Code: 71OTZ9ZE0A
Classification: ACTIM
CILASTATIN SODIUMActive
Quantity: 250 mg in 100 mL
Code: 5428WXZ74M
Classification: ACTIM

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PRIMAXIN - FDA Drug Approval Details