Cyclobenzaprine hydrochloride
- Product NDC
- 85509-1415
- 11-digit product format
- 855091415
- Labeler code
- 85509
- Product ID
- 85509-1415_4383b050-63c1-5a35-e063-6294a90a8a05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PHOENIX RX LLC
- Application
- ANDA213324
- Marketing category
- ANDA
- Marketing start
- 2020-07-06
- 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
- 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 table| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85509-1415-3 | Cyclobenzaprine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 85509-1415-6 | Cyclobenzaprine hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 85509-1415-9 | Cyclobenzaprine hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85509-1415-3 | 85509141503 | 30 TABLET, FILM COATED in 1 BOTTLE (85509-1415-3) | 2025-11-14 | No | No | Current |
| 85509-1415-6 | 85509141506 | 60 TABLET, FILM COATED in 1 BOTTLE (85509-1415-6) | 2025-11-14 | No | No | Current |
| 85509-1415-9 | 85509141509 | 90 TABLET, FILM COATED in 1 BOTTLE (85509-1415-9) | 2025-11-14 | No | No | Current |