| Product NDC: | 49349-494 |
| Proprietary Name: | Asacol |
| Non Proprietary Name: | MESALAMINE |
| Active Ingredient(s): | 400 mg/1 & nbsp; MESALAMINE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 49349-494 |
| Labeler Name: | REMEDYREPACK INC. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019651 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110817 |
| Package NDC: | 49349-494-23 |
| Package Description: | 180 TABLET in 1 CANISTER (49349-494-23) |
| NDC Code | 49349-494-23 |
| Proprietary Name | Asacol |
| Package Description | 180 TABLET in 1 CANISTER (49349-494-23) |
| Product NDC | 49349-494 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | MESALAMINE |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20110817 |
| Marketing Category Name | NDA |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | MESALAMINE |
| Strength Number | 400 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |