NDC 44004-321

FACTIVE

Gemifloxacin Mesylate

FACTIVE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Vansen Pharma Inc.. The primary component is Gemifloxacin Mesylate.

• Product ID: 44004-321_178042cd-894a-4368-a36b-1484bb1c012d
• NDC: 44004-321
• Product Type: Human Prescription Drug
• Proprietary Name: FACTIVE
• Generic Name: Gemifloxacin Mesylate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2003-04-04
• Marketing Category: NDA / NDA
• Application Number: NDA021158
• Labeler Name: Vansen Pharma Inc.
• Substance Name: GEMIFLOXACIN MESYLATE
• Active Ingredient Strength: 320 mg/1
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 44004-321-05

5 TABLET in 1 BLISTER PACK (44004-321-05)

• Marketing Start Date: 2003-04-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 44004-321-05 [44004032105]

FACTIVE TABLET

• Marketing Category: NDA
• Application Number: NDA021158
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-04-04
• Inactivation Date: 2019-11-27

NDC 44004-321-07 [44004032107]

FACTIVE TABLET

• Marketing Category: NDA
• Application Number: NDA021158
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-04-04
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
GEMIFLOXACIN MESYLATE	320 mg/1

OpenFDA Data

• SPL SET ID: 4502217c-3424-4453-a3ab-4bb2c35d2f0a
• Manufacturer:
  • Vansen Pharma Inc.
• UNII:
  • X4S9F8RL01
• RxNorm Concept Unique ID - RxCUI:
  • 637560
  • 637562
• UPC Code:
  • 0344004321052

Pharmacological Class

• Quinolone Antimicrobial [EPC]
• Quinolones [CS]

NDC Crossover Matching brand name "FACTIVE" or generic name "Gemifloxacin Mesylate"

NDC	Brand Name	Generic Name
44001-321	FACTIVE	gemifloxacin mesylate
44004-321	FACTIVE	gemifloxacin mesylate