Cyclobenzaprine Hydrochloride
- Product NDC
- 71335-2514
- 11-digit product format
- 713352514
- Labeler code
- 71335
- Product ID
- 71335-2514_3ef6e9bd-a57d-4a13-a845-f2dd47f895fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 15 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828358 |
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 |
|---|
| 71335-2514-1 | 71335251401 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2514-1) | 2024-10-24 | No | No | Historical |
| 71335-2514-2 | 71335251402 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2514-2) | 2024-10-24 | No | No | Historical |
| 71335-2514-3 | 71335251403 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2514-3) | 2024-10-24 | No | No | Historical |