ertapenem sodium

Generic: ertapenem sodium

Labeler: hikma pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ertapenem sodium 1 g/1

Manufacturer
Hikma Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0143-9398
Product ID 0143-9398_0563c487-5b62-46fe-a7e3-8ade454f1f4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208790
Listing Expiration 2026-12-31
Marketing Start 2021-08-02

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439398
Hyphenated Format 0143-9398

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 sodium (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 (0143-9398-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9398-01)
source: ndc

Packages (1)

0143-9398-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9398-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9398-01)

Ingredients (1)

ertapenem sodium (1 g/1)

Linked Drug Pages (1)

ertapenem sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "0563c487-5b62-46fe-a7e3-8ade454f1f4f", "openfda": {"unii": ["2T90KE67L0"], "rxcui": ["1734683"], "spl_set_id": ["a400707f-763f-43f6-989e-0d2569d822d8"], "manufacturer_name": ["Hikma Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9398-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9398-01)", "package_ndc": "0143-9398-10", "marketing_start_date": "20210802"}], "brand_name": "ertapenem sodium", "product_id": "0143-9398_0563c487-5b62-46fe-a7e3-8ade454f1f4f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "0143-9398", "generic_name": "ertapenem sodium", "labeler_name": "Hikma Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ertapenem sodium", "active_ingredients": [{"name": "ERTAPENEM SODIUM", "strength": "1 g/1"}], "application_number": "ANDA208790", "marketing_category": "ANDA", "marketing_start_date": "20210802", "listing_expiration_date": "20261231"}