| Product NDC: | 50532-066 |
| Proprietary Name: | Mesalamine |
| Non Proprietary Name: | Mesalamine |
| Active Ingredient(s): | 4 g/60mL & nbsp; Mesalamine |
| Administration Route(s): | RECTAL |
| Dosage Form(s): | SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50532-066 |
| Labeler Name: | Franklin Pharmaceutical LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019618 |
| Marketing Category: | NDA AUTHORIZED GENERIC |
| Start Marketing Date: | 20100401 |
| Package NDC: | 50532-066-03 |
| Package Description: | 4 TRAY in 1 CARTON (50532-066-03) > 7 BOTTLE, WITH APPLICATOR in 1 TRAY > 60 mL in 1 BOTTLE, WITH APPLICATOR (50532-066-06) |
| NDC Code | 50532-066-03 |
| Proprietary Name | Mesalamine |
| Package Description | 4 TRAY in 1 CARTON (50532-066-03) > 7 BOTTLE, WITH APPLICATOR in 1 TRAY > 60 mL in 1 BOTTLE, WITH APPLICATOR (50532-066-06) |
| Product NDC | 50532-066 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Mesalamine |
| Dosage Form Name | SUSPENSION |
| Route Name | RECTAL |
| Start Marketing Date | 20100401 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Labeler Name | Franklin Pharmaceutical LLC |
| Substance Name | MESALAMINE |
| Strength Number | 4 |
| Strength Unit | g/60mL |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |