CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 85766-003
- 11-digit product format
- 857660003
- Labeler code
- 85766
- Product ID
- 85766-003_4a8f971b-ad9c-5c85-e063-6394a90a9aff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- ANDA208170
- Marketing category
- ANDA
- Marketing start
- 2017-05-31
- 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
- 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 | 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 |
|---|
| 85766-003-00 | CYCLOBENZAPRINE HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
| 85766-003-01 | CYCLOBENZAPRINE HYDROCHLORIDE | 1 in 1 BOTTLE | TABLET, FILM COATED | 1 | | 4 |
| 85766-003-02 | CYCLOBENZAPRINE HYDROCHLORIDE | 2 in 1 BOTTLE | TABLET, FILM COATED | 2 | | 4 |
| 85766-003-04 | CYCLOBENZAPRINE HYDROCHLORIDE | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 4 |
| 85766-003-05 | CYCLOBENZAPRINE HYDROCHLORIDE | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 4 |
| 85766-003-07 | CYCLOBENZAPRINE HYDROCHLORIDE | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 4 |
| 85766-003-10 | CYCLOBENZAPRINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 85766-003-14 | CYCLOBENZAPRINE HYDROCHLORIDE | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 4 |
| 85766-003-20 | CYCLOBENZAPRINE HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 4 |
| 85766-003-21 | CYCLOBENZAPRINE HYDROCHLORIDE | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 4 |
| 85766-003-30 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 85766-003-50 | CYCLOBENZAPRINE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
| 85766-003-60 | CYCLOBENZAPRINE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 85766-003-90 | CYCLOBENZAPRINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-003-00 | 85766000300 | 1000 TABLET, FILM COATED in 1 BOTTLE (85766-003-00) | 2025-06-20 | No | No | Current |
| 85766-003-01 | 85766000301 | 1 TABLET, FILM COATED in 1 BOTTLE (85766-003-01) | 2025-06-20 | No | No | Current |
| 85766-003-02 | 85766000302 | 2 TABLET, FILM COATED in 1 BOTTLE (85766-003-02) | 2025-06-20 | No | No | Current |
| 85766-003-04 | 85766000304 | 4 TABLET, FILM COATED in 1 BOTTLE (85766-003-04) | 2025-06-20 | No | No | Current |
| 85766-003-05 | 85766000305 | 5 TABLET, FILM COATED in 1 BOTTLE (85766-003-05) | 2025-06-20 | No | No | Current |
| 85766-003-07 | 85766000307 | 7 TABLET, FILM COATED in 1 BOTTLE (85766-003-07) | 2025-06-20 | No | No | Current |
| 85766-003-10 | 85766000310 | 100 TABLET, FILM COATED in 1 BOTTLE (85766-003-10) | 2025-06-20 | No | No | Current |
| 85766-003-14 | 85766000314 | 14 TABLET, FILM COATED in 1 BOTTLE (85766-003-14) | 2026-02-11 | No | No | Current |
| 85766-003-20 | 85766000320 | 20 TABLET, FILM COATED in 1 BOTTLE (85766-003-20) | 2025-06-20 | No | No | Current |
| 85766-003-21 | 85766000321 | 21 TABLET, FILM COATED in 1 BOTTLE (85766-003-21) | 2026-02-11 | No | No | Current |
| 85766-003-30 | 85766000330 | 30 TABLET, FILM COATED in 1 BOTTLE (85766-003-30) | 2025-06-20 | No | No | Current |
| 85766-003-50 | 85766000350 | 500 TABLET, FILM COATED in 1 BOTTLE (85766-003-50) | 2025-06-20 | No | No | Current |
| 85766-003-60 | 85766000360 | 60 TABLET, FILM COATED in 1 BOTTLE (85766-003-60) | 2025-06-20 | No | No | Current |
| 85766-003-90 | 85766000390 | 90 TABLET, FILM COATED in 1 BOTTLE (85766-003-90) | 2025-06-20 | No | No | Current |