| Product NDC: | 0078-0385 |
| Proprietary Name: | Myfortic |
| Non Proprietary Name: | mycophenolic acid |
| Active Ingredient(s): | 180 mg/1 & nbsp; mycophenolic acid |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, DELAYED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0078-0385 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA050791 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20040227 |
| Package NDC: | 0078-0385-66 |
| Package Description: | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66) |
| NDC Code | 0078-0385-66 |
| Proprietary Name | Myfortic |
| Package Description | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66) |
| Product NDC | 0078-0385 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | mycophenolic acid |
| Dosage Form Name | TABLET, DELAYED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20040227 |
| Marketing Category Name | NDA |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | MYCOPHENOLATE SODIUM |
| Strength Number | 180 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Antimetabolite Immunosuppressant [EPC] |