Ertapenem

Ertapenem

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

Company

DUNS: 918601238

Effective Date

April 12, 2022

Labeling Type

Human Prescription Drug Label

Active Ingredients

Ertapenem(1 g in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Gland Pharma Limited

DUNS Number

858971074

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

NDC Product Code

68083-351

Application Number

ANDA212040

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

April 7, 2022

Ingredients

SODIUM BICARBONATEInactive

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

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

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT