Cyclobenzaprine Hydrochloride
- Product NDC
- 71610-933
- 11-digit product format
- 716100933
- Labeler code
- 71610
- Product ID
- 71610-933_3bc7e2c7-7cc9-adad-e063-6394a90ad5c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090478
- Marketing category
- ANDA
- Marketing start
- 2025-04-10
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 10 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 |
| 69O5WQQ5TI | CYCLOBENZAPRINE | 303-53-7 | Cyclobenzaprine |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-933-45 | 71610093345 | 45 TABLET in 1 BOTTLE (71610-933-45) | 45 tablet | 2025-08-06 | No | No | Historical |