Cyclobenzaprine Hydrochloride
- Product NDC
- 68071-3627
- 11-digit product format
- 680713627
- Labeler code
- 68071
- Product ID
- 68071-3627_1dda40fc-d423-9823-e063-6394a90ad0a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA071611
- Marketing category
- ANDA
- Marketing start
- 2021-07-20
- 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 |
|---|
| 68071-3627-5 | Cyclobenzaprine Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 2 |
| 68071-3627-7 | Cyclobenzaprine Hydrochloride | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3627 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 2 package rows | 20240724_1ac77323-7526-a129-e063-6394a90a641b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3627-5 | 68071362705 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3627-5) | 2024-06-13 | No | No | Historical |
| 68071-3627-7 | 68071362707 | 14 TABLET, FILM COATED in 1 BOTTLE (68071-3627-7) | 2024-06-13 | No | No | Historical |