ertapenem

Generic: ertapenem sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ertapenem
Generic Name ertapenem sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ertapenem sodium 1 g/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-823
Product ID 63323-823_8a08dc4b-9129-4b04-b586-19ca10abeafb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208790
Listing Expiration 2026-12-31
Marketing Start 2019-10-10

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323823
Hyphenated Format 63323-823

Supplemental Identifiers

RxCUI
1734683
UPC
0363323823016
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 ANDA208790 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-823-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (63323-823-01)
source: ndc

Packages (1)

63323-823-20 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-823-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (63323-823-01)

Ingredients (1)

ertapenem sodium (1 g/1)

Linked Drug Pages (1)

Ertapenem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "8a08dc4b-9129-4b04-b586-19ca10abeafb", "openfda": {"upc": ["0363323823016"], "unii": ["2T90KE67L0"], "rxcui": ["1734683"], "spl_set_id": ["666c9f33-ea9e-4667-b8bd-f8b1b6b6be51"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-823-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (63323-823-01)", "package_ndc": "63323-823-20", "marketing_start_date": "20191010"}], "brand_name": "Ertapenem", "product_id": "63323-823_8a08dc4b-9129-4b04-b586-19ca10abeafb", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "63323-823", "generic_name": "Ertapenem Sodium", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ertapenem", "active_ingredients": [{"name": "ERTAPENEM SODIUM", "strength": "1 g/1"}], "application_number": "ANDA208790", "marketing_category": "ANDA", "marketing_start_date": "20191010", "listing_expiration_date": "20261231"}