ERTAPENEM SODIUM

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

Company

DUNS: 830546433

Effective Date

December 28, 2023

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

NorthStar RxLLC

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

16714-889

Application Number

ANDA212040

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

December 28, 2023

Ingredients

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

Sodium BicarbonateInactive

Code: 8MDF5V39QOClass: IACT

Sodium HydroxideInactive

Code: 55X04QC32IClass: IACT