ertapenem sodium

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

Company

DUNS: 001230762

Effective Date

January 16, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ertapenem(1 g in 1 1)

Products1

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

NDC Product Code

0143-9398

Application Number

ANDA208790

Marketing Category

ANDA (C73584)

Route of Administration

INTRAMUSCULAR, INTRAVENOUS

Effective Date

February 26, 2021

Ingredients

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

sodium bicarbonateInactive

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

sodium hydroxideInactive

Code: 55X04QC32IClass: IACT