CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 68071-2453
- 11-digit product format
- 680712453
- Labeler code
- 68071
- Product ID
- 68071-2453_c50eef2e-af41-497a-e053-2a95a90a176e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA208170
- Marketing category
- ANDA
- Marketing start
- 2017-05-31
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2453 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 1 | Legacy NDC | 20210619_c50eef26-90ad-6fd7-e053-2995a90a11cb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2453-1 | 68071245301 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-2453-1) | 2021-06-18 | 0000-00-00 | No | No | Current |
| 68071-2453-9 | 68071245309 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-2453-9) | 2021-06-18 | 0000-00-00 | No | No | Current |