Cyclobenzaprine Hydrochloride
- Product NDC
- 55700-981
- 11-digit product format
- 557000981
- Labeler code
- 55700
- Product ID
- 55700-981_77971f19-d9e8-4452-ad42-5ed8a9224a4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- NDA021777
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-08-09
- Marketing end
- 0000-00-00
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 15 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55700-981 | CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [QUALITY CARE PRODUCTS, LLC] | 2 | Legacy NDC | 20241222_645517df-8a52-4fee-85a9-eca8c89e9069.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-981-60 | 55700098160 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-981-60) | 2022-08-09 | 0000-00-00 | No | No | Current |