NDC Code | 80425-0460-1 |
Package Description | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0460-1) |
Product NDC | 80425-0460 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Cyclobenzaprine Hydrochloride |
Non-Proprietary Name | Cyclobenzaprine Hydrochloride |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20241218 |
Marketing Category Name | ANDA |
Application Number | ANDA091281 |
Manufacturer | Advanced Rx of Tennessee, LLC |
Substance Name | CYCLOBENZAPRINE HYDROCHLORIDE |
Strength | 15 |
Strength Unit | mg/1 |
Pharmacy Classes | Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC] |