| NDC Code | 55700-578-01 |
|---|
| Package Description | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-578-01) |
|---|
| Product NDC | 55700-578 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Fexmid |
|---|
| Non-Proprietary Name | Cyclobenzaprine Hydrochloride |
|---|
| Dosage Form | TABLET, FILM COATED |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20180112 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA071611 |
|---|
| Manufacturer | Lake Erie Medical DBA Quality Care Products LLC |
|---|
| Substance Name | CYCLOBENZAPRINE HYDROCHLORIDE |
|---|
| Strength | 7.5 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] |
|---|