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FDA Approval

Ertapenem

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

FDA Approval Summary

Company
Eugia US LLC
DUNS: 968961354
Effective Date
November 10, 2022
Labeling Type
Human Prescription Drug Label
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.

EUGIA Pharma Specialities Limited

Eugia US LLC

864425497

Products1

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

Ertapenem

Product Details

NDC Product Code
55150-282
Application Number
ANDA209133
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
February 23, 2023
ErtapenemActive
Code: 2T90KE67L0Class: ACTIMQuantity: 1 g in 1 1
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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