NDC 44004-801

Spectracef

Cefditoren Pivoxil

Spectracef is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Vansen Pharma Inc.. The primary component is Cefditoren Pivoxil.

• Product ID: 44004-801_f99cc35f-6ffa-4f2e-bcdf-e51bb9a17c0d
• NDC: 44004-801
• Product Type: Human Prescription Drug
• Proprietary Name: Spectracef
• Generic Name: Cefditoren Pivoxil
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-02-05
• Marketing Category: NDA / NDA
• Application Number: NDA021222
• Labeler Name: Vansen Pharma Inc.
• Substance Name: CEFDITOREN PIVOXIL
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 44004-801-20

20 TABLET, FILM COATED in 1 BLISTER PACK (44004-801-20)

• Marketing Start Date: 2013-02-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 44004-801-20 [44004080120]

Spectracef TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021222
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-02-05
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
CEFDITOREN PIVOXIL	200 mg/1

OpenFDA Data

• SPL SET ID: 1c90b649-5536-417c-82cb-89663137f14f
• Manufacturer:
  • Vansen Pharma Inc.
• UNII:
  • 78THA212DH
• RxNorm Concept Unique ID - RxCUI:
  • 351127
  • 847365
  • 847362
  • 847360

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]

NDC Crossover Matching brand name "Spectracef" or generic name "Cefditoren Pivoxil"

NDC	Brand Name	Generic Name
44004-801	Spectracef	cefditoren pivoxil
44004-802	Spectracef	Cefditoren Pivoxil
44009-801	Cefditoren Pivoxil	cefditoren pivoxil
44009-802	Cefditoren Pivoxil	cefditoren pivoxil