Cyclobenzaprine Hydrochloride
- Product NDC
- 71205-454
- 11-digit product format
- 712050454
- Labeler code
- 71205
- Product ID
- 71205-454_a5a3c82e-1d99-4a5e-82c9-2d1f63f4dd6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA091281
- Marketing category
- ANDA
- Marketing start
- 2019-03-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0VE05JYS2P | CYCLOBENZAPRINE HYDROCHLORIDE | 6202-23-9 | CYCLOBENZAPRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-454-30 | 71205045430 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-30) | 2020-05-26 | No | No | Historical |
| 71205-454-42 | 71205045442 | 42 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-42) | 2020-05-26 | No | No | Historical |
| 71205-454-60 | 71205045460 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-60) | 2020-05-26 | No | No | Historical |
| 71205-454-90 | 71205045490 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-90) | 2020-05-26 | No | No | Historical |