Cyclobenzaprine hydrochloride
- Product NDC
- 76420-839
- 11-digit product format
- 764200839
- Labeler code
- 76420
- Product ID
- 76420-839_3b4cbe13-2679-7313-e063-6294a90a97ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- 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 |
|---|
| 76420-839-00 | 76420083900 | 1000 TABLET, FILM COATED in 1 BOTTLE (76420-839-00) | 2024-08-16 | No | No | Historical |
| 76420-839-01 | 76420083901 | 1 TABLET, FILM COATED in 1 BOTTLE (76420-839-01) | 2024-08-16 | No | No | Historical |
| 76420-839-02 | 76420083902 | 2 TABLET, FILM COATED in 1 BOTTLE (76420-839-02) | 2024-08-16 | No | No | Historical |
| 76420-839-05 | 76420083905 | 500 TABLET, FILM COATED in 1 BOTTLE (76420-839-05) | 2024-08-16 | No | No | Historical |
| 76420-839-07 | 76420083907 | 7 TABLET, FILM COATED in 1 BOTTLE (76420-839-07) | 2024-08-16 | No | No | Historical |
| 76420-839-10 | 76420083910 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-839-10) | 2024-08-16 | No | No | Historical |
| 76420-839-20 | 76420083920 | 20 TABLET, FILM COATED in 1 BOTTLE (76420-839-20) | 2024-08-16 | No | No | Historical |
| 76420-839-30 | 76420083930 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-839-30) | 2024-08-16 | No | No | Historical |
| 76420-839-60 | 76420083960 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-839-60) | 2024-08-16 | No | No | Historical |
| 76420-839-90 | 76420083990 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-839-90) | 2024-08-16 | No | No | Historical |