| Product NDC: | 68084-568 |
| Proprietary Name: | ASACOL |
| Non Proprietary Name: | mesalamine |
| Active Ingredient(s): | 400 mg/1 & nbsp; mesalamine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, DELAYED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68084-568 |
| Labeler Name: | American Health Packaging |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019651 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120123 |
| Package NDC: | 68084-568-21 |
| Package Description: | 3 BLISTER PACK in 1 CARTON (68084-568-21) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68084-568-11) |
| NDC Code | 68084-568-21 |
| Proprietary Name | ASACOL |
| Package Description | 3 BLISTER PACK in 1 CARTON (68084-568-21) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68084-568-11) |
| Product NDC | 68084-568 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | mesalamine |
| Dosage Form Name | TABLET, DELAYED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20120123 |
| Marketing Category Name | NDA |
| Labeler Name | American Health Packaging |
| Substance Name | MESALAMINE |
| Strength Number | 400 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |