cefotetan

Generic: cefotetan disodium

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

Drug Facts

Product Profile

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

cefotetan disodium 1 g/10mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-385
Product ID 63323-385_a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065374
Listing Expiration 2026-12-31
Marketing Start 2009-11-18

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323385
Hyphenated Format 63323-385

Supplemental Identifiers

RxCUI
1722919 1722921
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 cefotetan (source: ndc)
Generic Name cefotetan disodium (source: ndc)
Application Number ANDA065374 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/10mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (63323-385-10) / 10 mL in 1 VIAL (63323-385-01)
source: ndc

Packages (1)

63323-385-10 10 VIAL in 1 CARTON (63323-385-10) / 10 mL in 1 VIAL (63323-385-01)

Ingredients (1)

cefotetan disodium (1 g/10mL)

Linked Drug Pages (1)

Cefotetan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8", "openfda": {"unii": ["0GXP746VXB"], "rxcui": ["1722919", "1722921"], "spl_set_id": ["bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (63323-385-10)  / 10 mL in 1 VIAL (63323-385-01)", "package_ndc": "63323-385-10", "marketing_start_date": "20091118"}], "brand_name": "Cefotetan", "product_id": "63323-385_a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "63323-385", "generic_name": "CEFOTETAN DISODIUM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefotetan", "active_ingredients": [{"name": "CEFOTETAN DISODIUM", "strength": "1 g/10mL"}], "application_number": "ANDA065374", "marketing_category": "ANDA", "marketing_start_date": "20091118", "listing_expiration_date": "20261231"}