| NDC Code | 80425-0292-3 |
|---|
| Package Description | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-3) |
|---|
| 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] |
|---|