What are the ingredients in Factive?
- Active ingredient: gemifloxacin
Inactive ingredients: crospovidone, hydroxypropyl methycellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised October 2011
© Cornerstone Therapeutics Inc. 2011
FACTIVE is a registered trademark of LG Life Sciences.
Cornerstone Therapeutics Inc. Cary, NC 27518
Licensed from LG Life Sciences, Ltd. Seoul, Korea
Factive 5 Tablets
Factive 7 Tablets
| FACTIVE gemifloxacin mesylate tablet |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:10122-321 |
|Route of Administration ||ORAL ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|GEMIFLOXACIN MESYLATE (GEMIFLOXACIN) ||GEMIFLOXACIN ||320 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| CROSPOVIDONE || |
| MAGNESIUM STEARATE || |
| CELLULOSE, MICROCRYSTALLINE || |
| POVIDONE || |
| TITANIUM DIOXIDE || |
| HYPROMELLOSE 2910 (15 MPA.S) || |
| HYPROMELLOSE 2910 (5 MPA.S) || |
| POLYETHYLENE GLYCOL 4000 || |
| POLYETHYLENE GLYCOL 6000 || |
|Product Characteristics |
|Color ||WHITE (white to off-white) ||Score ||2 pieces |
|Shape ||OVAL ||Size ||16mm |
|Flavor || ||Imprint Code ||GE;320 |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:10122-321-05 ||5 TABLET (5 TABLET) in 1 BLISTER PACK ||None |
| 2 ||NDC:10122-321-07 ||7 TABLET (7 TABLET) in 1 BLISTER PACK ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|NDA ||NDA021158 ||04/04/2003 || |
|Labeler — Cornerstone Therapeutics Inc.
Revised: 11/2011 Cornerstone Therapeutics Inc.
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