Cyclobenzaprine hydrochloride
- Product NDC
- 71335-1962
- 11-digit product format
- 713351962
- Labeler code
- 71335
- Product ID
- 71335-1962_081b5e7c-a504-8d76-e063-6294a90a821f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213324
- Marketing category
- ANDA
- Marketing start
- 2020-07-06
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828348 |
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 |
|---|
| 71335-1962-0 | 71335196200 | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1962-0) | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1962-1 | 71335196201 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-1962-1) | 2021-10-11 | 0000-00-00 | No | No | Current |
| 71335-1962-2 | 71335196202 | 84 TABLET, FILM COATED in 1 BOTTLE (71335-1962-2) | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1962-3 | 71335196203 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1962-3) | 2021-10-08 | 0000-00-00 | No | No | Current |
| 71335-1962-4 | 71335196204 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1962-4) | 2021-10-08 | 0000-00-00 | No | No | Current |
| 71335-1962-5 | 71335196205 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1962-5) | 2021-12-30 | 0000-00-00 | No | No | Current |
| 71335-1962-6 | 71335196206 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1962-6) | 2021-10-08 | 0000-00-00 | No | No | Current |
| 71335-1962-7 | 71335196207 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1962-7) | 2021-10-08 | 0000-00-00 | No | No | Current |
| 71335-1962-8 | 71335196208 | 56 TABLET, FILM COATED in 1 BOTTLE (71335-1962-8) | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1962-9 | 71335196209 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1962-9) | 2021-11-16 | 0000-00-00 | No | No | Current |