NDC 44009-801

Cefditoren Pivoxil

Cefditoren Pivoxil

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

• Product ID: 44009-801_edeaf75d-92f5-4fef-a127-ad200561aa71
• NDC: 44009-801
• Product Type: Human Prescription Drug
• Proprietary Name: Cefditoren Pivoxil
• Generic Name: Cefditoren Pivoxil
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-02-12
• Marketing Category: NDA / NDA
• Application Number: NDA021222
• Labeler Name: Pharma RomLev 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 44009-801-20

20 TABLET, FILM COATED in 1 BLISTER PACK (44009-801-20)

• Marketing Start Date: 2013-02-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 44009-801-20 [44009080120]

Cefditoren Pivoxil TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021222
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-02-12
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
CEFDITOREN PIVOXIL	200 mg/1

OpenFDA Data

• SPL SET ID: d5050d0e-81d1-4707-a38a-e80de2aebf09
• Manufacturer:
  • Pharma RomLev Inc.
• UNII:
  • 78THA212DH
• RxNorm Concept Unique ID - RxCUI:
  • 351127
  • 847360

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]

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

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