Cyclobenzaprine Hydrochloride
- Product NDC
- 43063-917
- 11-digit product format
- 430630917
- Labeler code
- 43063
- Product ID
- 43063-917_e6d9b23d-5317-5d55-e053-2995a90add4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078048
- Marketing category
- ANDA
- Marketing start
- 2014-07-31
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-917 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 13 | Legacy NDC | 20241018_5c55ee6e-4371-46ad-8426-ef9fbd018abf.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-917-15 | 43063091715 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-917-15) | 2018-12-12 | 0000-00-00 | No | No | Current |