| Product NDC: | 0054-0079 |
| Proprietary Name: | Balsalazide Disodium |
| Non Proprietary Name: | Balsalazide Disodium |
| Active Ingredient(s): | 750 mg/1 & nbsp; Balsalazide Disodium |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0054-0079 |
| Labeler Name: | Roxane Laboratories, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077806 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20071228 |
| Package NDC: | 0054-0079-28 |
| Package Description: | 280 CAPSULE in 1 BOTTLE (0054-0079-28) |
| NDC Code | 0054-0079-28 |
| Proprietary Name | Balsalazide Disodium |
| Package Description | 280 CAPSULE in 1 BOTTLE (0054-0079-28) |
| Product NDC | 0054-0079 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Balsalazide Disodium |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20071228 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc |
| Substance Name | BALSALAZIDE DISODIUM |
| Strength Number | 750 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |