CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 68071-3561
- 11-digit product format
- 680713561
- Labeler code
- 68071
- Product ID
- 68071-3561_149278a3-d3a4-c55b-e063-6294a90ab196
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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
- 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 |
|---|
| 68071-3561-4 | CYCLOBENZAPRINE HYDROCHLORIDE | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 2 |
| 68071-3561-6 | CYCLOBENZAPRINE HYDROCHLORIDE | 9 in 1 BOTTLE | TABLET, FILM COATED | 9 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3561 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 2 package rows | 20240328_0f8ba2c0-38e7-a536-e063-6294a90ace8d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3561-4 | 68071356104 | 4 TABLET, FILM COATED in 1 BOTTLE (68071-3561-4) | 2024-01-02 | No | No | Historical |
| 68071-3561-6 | 68071356106 | 9 TABLET, FILM COATED in 1 BOTTLE (68071-3561-6) | 2024-01-02 | No | No | Historical |