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] |