Cyclobenzaprine Hydrochloride
- Product NDC
- 68788-4087
- 11-digit product format
- 687884087
- Labeler code
- 68788
- Product ID
- 68788-4087_96b650d8-4ad5-42af-aa8c-aa0ac25abfb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- NDA021777
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2026-03-17
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828358 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-4087-3 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 1 |
| 68788-4087-6 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4087-3 | 68788408703 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-4087-3) | 2026-03-17 | No | No | Historical |
| 68788-4087-6 | 68788408706 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-4087-6) | 2026-03-17 | No | No | Historical |