CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 68788-8474
- 11-digit product format
- 687888474
- Labeler code
- 68788
- Product ID
- 68788-8474_b5fcab9c-b8d2-411f-a07f-1288cc363348
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA208170
- Marketing category
- ANDA
- Marketing start
- 2023-07-01
- 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
- 2027-12-31
- 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 |
|---|
| 68788-8474-2 | 68788847402 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8474-2) | 2023-07-01 | No | No | Historical |
| 68788-8474-3 | 68788847403 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8474-3) | 2023-07-01 | No | No | Historical |
| 68788-8474-5 | 68788847405 | 15 TABLET, FILM COATED in 1 BOTTLE (68788-8474-5) | 2023-07-01 | No | No | Historical |
| 68788-8474-6 | 68788847406 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8474-6) | 2023-07-01 | No | No | Historical |
| 68788-8474-9 | 68788847409 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8474-9) | 2023-07-01 | No | No | Historical |