CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 68071-3462
- 11-digit product format
- 680713462
- Labeler code
- 68071
- Product ID
- 68071-3462_14a7402c-8406-3acb-e063-6394a90a6b7f
- 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
- 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 |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3462-2 | 68071346202 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-3462-2) | 2023-07-19 | No | No | Historical |
| 68071-3462-3 | 68071346203 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3462-3) | 2023-07-31 | No | No | Historical |
| 68071-3462-5 | 68071346205 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3462-5) | 2023-07-19 | No | No | Historical |