NDC Code | 53002-0523-5 |
Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (53002-0523-5) |
Product NDC | 53002-0523 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Cyclobenzaprine Hydrochloride |
Non-Proprietary Name | Cyclobenzaprine Hydrochloride |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20200706 |
Marketing Category Name | ANDA |
Application Number | ANDA213324 |
Manufacturer | RPK Pharmaceuticals, Inc. |
Substance Name | CYCLOBENZAPRINE HYDROCHLORIDE |
Strength | 5 |
Strength Unit | mg/1 |
Pharmacy Classes | Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC] |