10122-321 : Factive 320 mg Oral Tablet


NDC10122-321
Labeler: Cornerstone Therapeutics Inc.
Product Type: Human Prescription Drug
Drug Name:  Factive
Dosage Form: Oral Tablet
Application #: NDA021158
Rev. Date: 


Appearance:


Markings: GE;320
Shapes:  Oval
Colors:  White
Size (mm): 16
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

  • 10122-321-05: 5 TABLET IN 1 BLISTER PACK (10122‑321‑05)
  • 10122-321-07: 7 TABLET IN 1 BLISTER PACK (10122‑321‑07)

Active Ingredients:

  • Gemifloxacin Mesylate

Dosage Strength:

  • 320 mg

Inactive Ingredients:

  • Crospovidone
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidone
  • Titanium Dioxide
  • Hypromellose 2910 (15 Mpa.s)
  • Hypromellose 2910 (5 Mpa.s)
  • Polyethylene Glycol 4000
  • Polyethylene Glycol 6000

Pharmaceutical Classes:

  • Quinolone Antimicrobial [EPC]
  • Quinolones [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 44001-321 Factive 320 mg Oral Tablet by Merus Labs International Inc.
  • 44004-321 Factive (Gemifloxacin 320 mg) by Vansen Pharma Inc.
  • 67707-320 Factive 320 mg Oral Tablet by Oscient Pharmaceuticals

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.