Cyclobenzaprine HCL
- Product NDC
- 80425-0292
- 11-digit product format
- 804250292
- Labeler code
- 80425
- Product ID
- 80425-0292_2a9bfe6a-6d67-b262-e063-6294a90a1cf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine HCL
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- NDA021777
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-03-31
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0VE05JYS2P | CYCLOBENZAPRINE HYDROCHLORIDE | 6202-23-9 | CYCLOBENZAPRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0292-1 | 80425029201 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-1) | 2023-03-31 | No | No | Historical |
| 80425-0292-2 | 80425029202 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-2) | 2023-03-31 | No | No | Historical |
| 80425-0292-3 | 80425029203 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-3) | 2023-03-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Cyclobenzaprine HCL ER Capsule | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |