Cyclobenzaprine Hydrochloride
- Product NDC
- 68071-3915
- 11-digit product format
- 680713915
- Labeler code
- 68071
- Product ID
- 68071-3915_4511ceb6-8ad3-20d4-e063-6394a90ae4d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA208170
- Marketing category
- ANDA
- Marketing start
- 2017-05-31
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 5 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 |
|---|
| 68071-3915-2 | 68071391502 | 12 TABLET, FILM COATED in 1 BOTTLE (68071-3915-2) | 2025-11-17 | No | No | Historical |
| 68071-3915-3 | 68071391503 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3915-3) | 2025-12-03 | No | No | Historical |