| Product NDC: | 0430-0753 |
| Proprietary Name: | Delzicol |
| Non Proprietary Name: | mesalamine |
| Active Ingredient(s): | 400 mg/1 & nbsp; mesalamine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, DELAYED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0430-0753 |
| Labeler Name: | Warner Chilcott (US), LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA204412 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130301 |
| Package NDC: | 0430-0753-95 |
| Package Description: | 4 TRAY in 1 CASE (0430-0753-95) > 6 CARTON in 1 TRAY > 1 BOTTLE in 1 CARTON > 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
| NDC Code | 0430-0753-95 |
| Proprietary Name | Delzicol |
| Package Description | 4 TRAY in 1 CASE (0430-0753-95) > 6 CARTON in 1 TRAY > 1 BOTTLE in 1 CARTON > 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
| Product NDC | 0430-0753 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | mesalamine |
| Dosage Form Name | CAPSULE, DELAYED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20130301 |
| Marketing Category Name | NDA |
| Labeler Name | Warner Chilcott (US), LLC |
| Substance Name | MESALAMINE |
| Strength Number | 400 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |