ERTAPENEM SODIUM

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

Company

Dr.Reddys Laboratories Inc.,

DUNS: 802315887

Effective Date

April 30, 2021

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

Dr.Reddys Laboratories Inc.,

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

43598-901

Application Number

ANDA212040

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

April 8, 2021

Ingredients

Sodium BicarbonateInactive

Code: 8MDF5V39QOClass: IACT

Sodium HydroxideInactive

Code: 55X04QC32IClass: IACT

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