| Product NDC: | 16590-699 |
| Proprietary Name: | FEXMID |
| Non Proprietary Name: | CYCLOBENZAPRINE HYDROCHLORIDE |
| Active Ingredient(s): | 7.5 mg/1 & nbsp; CYCLOBENZAPRINE HYDROCHLORIDE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-699 |
| Labeler Name: | STAT Rx USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA071611 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20081101 |
| Package NDC: | 16590-699-90 |
| Package Description: | 90 TABLET, FILM COATED in 1 BOTTLE (16590-699-90) |
| NDC Code | 16590-699-90 |
| Proprietary Name | FEXMID |
| Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (16590-699-90) |
| Product NDC | 16590-699 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | CYCLOBENZAPRINE HYDROCHLORIDE |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20081101 |
| Marketing Category Name | ANDA |
| Labeler Name | STAT Rx USA LLC |
| Substance Name | CYCLOBENZAPRINE HYDROCHLORIDE |
| Strength Number | 7.5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] |