cefotetan

Generic: cefotetan

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

Drug Facts

Product Profile

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

cefotetan 2 g/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9671
Product ID 0143-9671_239c7e32-be35-41ea-b466-2e15d3339398
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091031
Listing Expiration 2026-12-31
Marketing Start 2011-10-26

Pharmacologic Class

Established (EPC)
cephalosporin antibacterial [epc]
Chemical Structure
cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439671
Hyphenated Format 0143-9671

Supplemental Identifiers

RxCUI
1722919 1722921
UNII
48SPP0PA9Q
NUI
N0000175488 M0003827

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 cefotetan (source: ndc)
Generic Name cefotetan (source: ndc)
Application Number ANDA091031 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 g/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9671-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9671-01)
source: ndc

Packages (1)

0143-9671-10 10 VIAL in 1 CARTON (0143-9671-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9671-01)

Ingredients (1)

cefotetan (2 g/1)

Linked Drug Pages (1)

Cefotetan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "239c7e32-be35-41ea-b466-2e15d3339398", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["48SPP0PA9Q"], "rxcui": ["1722919", "1722921"], "spl_set_id": ["33b13b93-58ce-44c7-b9a2-af3b3a333f80"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9671-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9671-01)", "package_ndc": "0143-9671-10", "marketing_start_date": "20111026"}], "brand_name": "Cefotetan", "product_id": "0143-9671_239c7e32-be35-41ea-b466-2e15d3339398", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "0143-9671", "generic_name": "Cefotetan", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefotetan", "active_ingredients": [{"name": "CEFOTETAN", "strength": "2 g/1"}], "application_number": "ANDA091031", "marketing_category": "ANDA", "marketing_start_date": "20111026", "listing_expiration_date": "20261231"}