Cyclobenzaprine Hydrochloride
- Product NDC
- 63629-1212
- 11-digit product format
- 636291212
- Labeler code
- 63629
- Product ID
- 63629-1212_c000dfb8-781e-41aa-84eb-2fe5dad1bc77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077797
- Marketing category
- ANDA
- Marketing start
- 2017-03-30
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828320 |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-1212-1 | 63629121201 | 500 TABLET, FILM COATED in 1 BOTTLE (63629-1212-1) | 2021-01-14 | 0000-00-00 | No | No | Current |