ertapenem

Generic: ertapenem sodium

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ertapenem
Generic Name ertapenem sodium
Labeler sagent pharmaceuticals
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ertapenem sodium 1 g/1

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-199
Product ID 25021-199_0a3ba6c5-088b-4c94-8ece-b76034ecccb8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218067
Listing Expiration 2026-12-31
Marketing Start 2025-08-15

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021199
Hyphenated Format 25021-199

Supplemental Identifiers

RxCUI
1734683
UNII
2T90KE67L0

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ertapenem (source: ndc)
Generic Name ertapenem sodium (source: ndc)
Application Number ANDA218067 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-199-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

25021-199-20 10 VIAL in 1 CARTON (25021-199-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

ertapenem sodium (1 g/1)

Linked Drug Pages (2)

Ertapenem ndc-match (0.9) Ertapenem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "0a3ba6c5-088b-4c94-8ece-b76034ecccb8", "openfda": {"unii": ["2T90KE67L0"], "rxcui": ["1734683"], "spl_set_id": ["39bd4d41-36f8-4826-a733-a5ad1a531c02"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-199-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "25021-199-20", "marketing_start_date": "20250815"}], "brand_name": "Ertapenem", "product_id": "25021-199_0a3ba6c5-088b-4c94-8ece-b76034ecccb8", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "25021-199", "generic_name": "Ertapenem Sodium", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ertapenem", "active_ingredients": [{"name": "ERTAPENEM SODIUM", "strength": "1 g/1"}], "application_number": "ANDA218067", "marketing_category": "ANDA", "marketing_start_date": "20250815", "listing_expiration_date": "20261231"}