NDC 52565-053

CEFOTAN

Cefotetan Disodium

CEFOTAN is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Teligent Pharma, Inc.. The primary component is Cefotetan Disodium.

• Product ID: 52565-053_675e1e86-13c2-4287-b4ed-cc60d01b9acc
• NDC: 52565-053
• Product Type: Human Prescription Drug
• Proprietary Name: CEFOTAN
• Generic Name: Cefotetan Disodium
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2015-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA050588
• Labeler Name: Teligent Pharma, Inc.
• Substance Name: CEFOTETAN DISODIUM
• Active Ingredient Strength: 2 g/20mL
• Pharm Classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52565-053-10

10 VIAL in 1 TRAY (52565-053-10) > 20 mL in 1 VIAL

• Marketing Start Date: 2015-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52565-053-10 [52565005310]

CEFOTAN INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA050588
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-01

Drug Details

Active Ingredients

Ingredient	Strength
CEFOTETAN DISODIUM	2 g/20mL

OpenFDA Data

• SPL SET ID: 0860bfe0-da3e-4460-da57-2411db14c426
• Manufacturer:
  • Teligent Pharma, Inc.
• UNII:
  • 0GXP746VXB
• RxNorm Concept Unique ID - RxCUI:
  • 1722919
  • 1731542
  • 1743557
  • 1722921

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]
• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]

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

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