NDC 44001-321

FACTIVE

Gemifloxacin Mesylate

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

• Product ID: 44001-321_f5157025-9ab5-4697-81bc-1adb13ea1dfc
• NDC: 44001-321
• 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: Merus Labs International 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 44001-321-07

7 TABLET in 1 BLISTER PACK (44001-321-07)

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

NDC SPL Data Element Entries

NDC 44001-321-05 [44001032105]

FACTIVE TABLET

• Marketing Category: NDA
• Application Number: NDA021158
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-04-04
• Inactivation Date: 2020-01-31

NDC 44001-321-07 [44001032107]

FACTIVE TABLET

• Marketing Category: NDA
• Application Number: NDA021158
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-04-04
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
GEMIFLOXACIN MESYLATE	320 mg/1

OpenFDA Data

• SPL SET ID: 63f60426-e27f-4258-9bfc-b4a15ebdca83
• Manufacturer:
  • Merus Labs International Inc.
• UNII:
  • X4S9F8RL01
• RxNorm Concept Unique ID - RxCUI:
  • 637560
  • 637562

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