Cyclobenzaprine Hydrochloride
- Product NDC
- 76420-019
- 11-digit product format
- 764200019
- Labeler code
- 76420
- Product ID
- 76420-019_a73bd6a8-be64-4e54-e053-2a95a90a88a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2018-01-16
- Marketing end
- 0000-00-00
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-019 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.] | 1 | Legacy NDC | 20200606_354286fa-7a64-4873-a188-14de8e86f677.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-019-30 | 76420001930 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-019-30) | 2020-06-04 | 0000-00-00 | No | No | Current |
| 76420-019-60 | 76420001960 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-019-60) | 2020-06-04 | 0000-00-00 | No | No | Current |
| 76420-019-90 | 76420001990 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-019-90) | 2020-06-04 | 0000-00-00 | No | No | Current |