| Product NDC: | 50458-396 |
| Proprietary Name: | RAZADYNE |
| Non Proprietary Name: | galantamine hydrobromide |
| Active Ingredient(s): | 4 mg/1 & nbsp; galantamine hydrobromide |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50458-396 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021169 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20010301 |
| Package NDC: | 50458-396-60 |
| Package Description: | 60 TABLET, FILM COATED in 1 BOTTLE (50458-396-60) |
| NDC Code | 50458-396-60 |
| Proprietary Name | RAZADYNE |
| Package Description | 60 TABLET, FILM COATED in 1 BOTTLE (50458-396-60) |
| Product NDC | 50458-396 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | galantamine hydrobromide |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20010301 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | GALANTAMINE HYDROBROMIDE |
| Strength Number | 4 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] |