NDC Code | 80425-0292-2 |
Package Description | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-2) |
Product NDC | 80425-0292 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Cyclobenzaprine Hcl |
Proprietary Name Suffix | Er |
Non-Proprietary Name | Cyclobenzaprine Hcl |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20230331 |
Marketing Category Name | NDA AUTHORIZED GENERIC |
Application Number | NDA021777 |
Manufacturer | Advanced Rx Pharmacy of Tennessee, LLC |
Substance Name | CYCLOBENZAPRINE HYDROCHLORIDE |
Strength | 15 |
Strength Unit | mg/1 |
Pharmacy Classes | Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC] |