ertapenem

Generic: ertapenem sodium

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ertapenem
Generic Name ertapenem sodium
Labeler apotex corp
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ertapenem sodium 1 g/20mL

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-6196
Product ID 60505-6196_0c5d06ec-0530-f60c-e063-6394a90a79b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207647
Listing Expiration 2026-12-31
Marketing Start 2019-04-02

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056196
Hyphenated Format 60505-6196

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 ANDA207647 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/20mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (60505-6196-4) / 20 mL in 1 VIAL (60505-6196-0)
source: ndc

Packages (1)

60505-6196-4 10 VIAL in 1 CARTON (60505-6196-4) / 20 mL in 1 VIAL (60505-6196-0)

Ingredients (1)

ertapenem sodium (1 g/20mL)

Linked Drug Pages (1)

Ertapenem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "0c5d06ec-0530-f60c-e063-6394a90a79b9", "openfda": {"unii": ["2T90KE67L0"], "rxcui": ["1734683"], "spl_set_id": ["468105b9-48b3-4477-82c7-e7fb92460e28"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (60505-6196-4)  / 20 mL in 1 VIAL (60505-6196-0)", "package_ndc": "60505-6196-4", "marketing_start_date": "20190402"}], "brand_name": "Ertapenem", "product_id": "60505-6196_0c5d06ec-0530-f60c-e063-6394a90a79b9", "dosage_form": "INJECTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "60505-6196", "generic_name": "Ertapenem Sodium", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ertapenem", "active_ingredients": [{"name": "ERTAPENEM SODIUM", "strength": "1 g/20mL"}], "application_number": "ANDA207647", "marketing_category": "ANDA", "marketing_start_date": "20190402", "listing_expiration_date": "20261231"}