| Product NDC: | 0149-0783 |
| Proprietary Name: | Asacol HD |
| Non Proprietary Name: | mesalamine |
| Active Ingredient(s): | 800 mg/1 & nbsp; mesalamine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, DELAYED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0149-0783 |
| Labeler Name: | Procter & Gamble Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021830 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090528 |
| Package NDC: | 0149-0783-01 |
| Package Description: | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0149-0783-01) |
| NDC Code | 0149-0783-01 |
| Proprietary Name | Asacol HD |
| Package Description | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0149-0783-01) |
| Product NDC | 0149-0783 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | mesalamine |
| Dosage Form Name | TABLET, DELAYED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20090528 |
| Marketing Category Name | NDA |
| Labeler Name | Procter & Gamble Pharmaceuticals, Inc. |
| Substance Name | MESALAMINE |
| Strength Number | 800 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |