Cyclobenzaprine Hydrochloride
- Product NDC
- 68071-2790
- 11-digit product format
- 680712790
- Labeler code
- 68071
- Product ID
- 68071-2790_39732f45-1ec5-775f-e063-6294a90a8724
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA078643
- Marketing category
- ANDA
- Marketing start
- 2008-09-26
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828320 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2790-1 | Cyclobenzaprine Hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 4 |
| 68071-2790-2 | Cyclobenzaprine Hydrochloride | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | | 4 |
| 68071-2790-6 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 68071-2790-7 | Cyclobenzaprine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2790 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20250130_e3b5fc92-9186-6944-e053-2a95a90a1c9f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2790-1 | 68071279001 | 10 TABLET, FILM COATED in 1 BOTTLE (68071-2790-1) | 2025-07-08 | | No | No | Historical |
| 68071-2790-2 | 68071279002 | 12 TABLET, FILM COATED in 1 BOTTLE (68071-2790-2) | 2022-07-13 | 0000-00-00 | No | No | Current |
| 68071-2790-6 | 68071279006 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-2790-6) | 2023-06-20 | | No | No | Historical |
| 68071-2790-7 | 68071279007 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-2790-7) | 2025-01-28 | | No | No | Historical |