Cyclobenzaprine HCL
- Product NDC
- 80425-0015
- 11-digit product format
- 804250015
- Labeler code
- 80425
- Product ID
- 80425-0015_ed0c581e-ff7e-b4f4-e053-2a95a90ab431
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine HCL
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ADVANCED RX PHARMACY OF TENNESSEE, LLC
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0015-1 | 80425001501 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0015-1) | 2018-01-16 | 0000-00-00 | No | No | Current |
| 80425-0015-2 | 80425001502 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0015-2) | 2018-01-16 | 0000-00-00 | No | No | Current |
| 80425-0015-3 | 80425001503 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0015-3) | 2018-01-16 | 0000-00-00 | No | No | Current |