ERTAPENEM

ERTAPENEM

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 092733690

Effective Date

November 7, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ertapenem(1 g in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

DUNS Number

118446553

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

42023-221

Application Number

NDA021337

Marketing Category

NDA (C73594)

Route of Administration

INTRAMUSCULAR, INTRAVENOUS

Effective Date

November 7, 2022

Ingredients

Code: 2T90KE67L0Class: ACTIMQuantity: 1 g in 1 1

sodium bicarbonateInactive

Code: 8MDF5V39QOClass: IACTQuantity: 175 mg in 1 1

sodium hydroxideInactive

Code: 55X04QC32IClass: IACT