CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 70934-442
- 11-digit product format
- 709340442
- Labeler code
- 70934
- Product ID
- 70934-442_a798cd55-e0fa-328d-e053-2a95a90a3d69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA208170
- Marketing category
- ANDA
- Marketing start
- 2019-09-17
- 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
- 2021-12-31
- 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 |
|---|
| 70934-442-06 | 70934044206 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-442-06) | 2020-04-27 | 0000-00-00 | No | No | Current |
| 70934-442-10 | 70934044210 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-442-10) | 2020-01-28 | 0000-00-00 | No | No | Current |
| 70934-442-15 | 70934044215 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-442-15) | 2019-09-17 | 0000-00-00 | No | No | Current |
| 70934-442-20 | 70934044220 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-442-20) | 2019-09-17 | 0000-00-00 | No | No | Current |
| 70934-442-30 | 70934044230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-442-30) | 2019-11-01 | 0000-00-00 | No | No | Current |
| 70934-442-60 | 70934044260 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-442-60) | 2020-02-19 | 0000-00-00 | No | No | Current |
| 70934-442-90 | 70934044290 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-442-90) | 2020-05-08 | 0000-00-00 | No | No | Current |