 
                        | Product NDC: | 12634-980 | 
| Proprietary Name: | MISOPROSTOL | 
| Non Proprietary Name: | MISOPROSTOL | 
| Active Ingredient(s): | 100 ug/1 & nbsp; MISOPROSTOL | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 12634-980 | 
| Labeler Name: | Apotheca, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA076095 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20100225 | 
| Package NDC: | 12634-980-78 | 
| Package Description: | 28 TABLET in 1 BOTTLE (12634-980-78) | 
| NDC Code | 12634-980-78 | 
| Proprietary Name | MISOPROSTOL | 
| Package Description | 28 TABLET in 1 BOTTLE (12634-980-78) | 
| Product NDC | 12634-980 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | MISOPROSTOL | 
| Dosage Form Name | TABLET | 
| Route Name | ORAL | 
| Start Marketing Date | 20100225 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Apotheca, Inc. | 
| Substance Name | MISOPROSTOL | 
| Strength Number | 100 | 
| Strength Unit | ug/1 | 
| Pharmaceutical Classes | Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] |