cefotan

Generic: cefotetan

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefotan
Generic Name cefotetan
Labeler pai holdings, llc dba pai pharma
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

cefotetan disodium 1 g/10mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0976
Product ID 0121-0976_7e29cb53-c401-49b0-9b47-209601f7ec55
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050588
Listing Expiration 2026-12-31
Marketing Start 2024-04-08

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210976
Hyphenated Format 0121-0976

Supplemental Identifiers

RxCUI
1722919 1722921 1731542 1743557
UNII
0GXP746VXB

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 cefotan (source: ndc)
Generic Name cefotetan (source: ndc)
Application Number NDA050588 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/10mL
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (0121-0976-10) / 10 mL in 1 VIAL (0121-0976-55)
source: ndc

Packages (1)

0121-0976-10 10 VIAL in 1 TRAY (0121-0976-10) / 10 mL in 1 VIAL (0121-0976-55)

Ingredients (1)

cefotetan disodium (1 g/10mL)

Linked Drug Pages (1)

Cefotan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "7e29cb53-c401-49b0-9b47-209601f7ec55", "openfda": {"unii": ["0GXP746VXB"], "rxcui": ["1722919", "1722921", "1731542", "1743557"], "spl_set_id": ["f1510f5e-d001-44e0-accb-27cf79fd4f9a"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (0121-0976-10)  / 10 mL in 1 VIAL (0121-0976-55)", "package_ndc": "0121-0976-10", "marketing_start_date": "20240408"}], "brand_name": "Cefotan", "product_id": "0121-0976_7e29cb53-c401-49b0-9b47-209601f7ec55", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "0121-0976", "generic_name": "Cefotetan", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefotan", "active_ingredients": [{"name": "CEFOTETAN DISODIUM", "strength": "1 g/10mL"}], "application_number": "NDA050588", "marketing_category": "NDA", "marketing_start_date": "20240408", "listing_expiration_date": "20261231"}