NDC 63323-385

Cefotetan

Cefotetan Disodium

Cefotetan is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Cefotetan Disod.

• Product ID: 63323-385_5031dbeb-af22-42af-a047-9e0e8dfaf18c
• NDC: 63323-385
• Product Type: Human Prescription Drug
• Proprietary Name: Cefotetan
• Generic Name: Cefotetan Disodium
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2009-11-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065374
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: CEFOTETAN DISOD
• Active Ingredient Strength: 1 g/10mL
• Pharm Classes: Cephalosporin A
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63323-385-10

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

• Marketing Start Date: 2009-11-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-385-10 [63323038510]

Cefotetan INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065374
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-11-18

Drug Details

Active Ingredients

Ingredient	Strength
CEFOTETAN DISODIUM	1 g/10mL

OpenFDA Data

• SPL SET ID: bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 0GXP746VXB
• RxNorm Concept Unique ID - RxCUI:
  • 1722919
  • 1722921

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]

NDC Crossover Matching brand name "Cefotetan" or generic name "Cefotetan Disodium"

NDC	Brand Name	Generic Name
0143-9670	Cefotetan	Cefotetan
0143-9671	Cefotetan	Cefotetan
63323-385	Cefotetan	CEFOTETAN DISODIUM
63323-386	Cefotetan	CEFOTETAN DISODIUM
63323-396	Cefotetan	CEFOTETAN DISODIUM
52565-052	Cefotan	Cefotetan Disodium
52565-053	CEFOTAN	cefotetan disodium