Cyclobenzaprine hydrochloride
- Product NDC
- 0615-8508
- 11-digit product format
- 006158508
- Labeler code
- 0615
- Product ID
- 0615-8508_dc545abc-ee5b-4f19-ba1e-d0643186f2f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA213324
- Marketing category
- ANDA
- Marketing start
- 2020-07-06
- 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 |
|---|
| 0615-8508-05 | 00615850805 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-05) | 2024-05-16 | No | No | Historical |
| 0615-8508-39 | 00615850839 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-39) | 2024-05-16 | No | No | Historical |