Cyclobenzaprine hydrochloride
- Product NDC
- 0615-8508
- 11-digit product format
- 006158508
- Labeler code
- 0615
- Product ID
- 0615-8508_dc545abc-ee5b-4f19-ba1e-d0643186f2f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA213324
- Marketing category
- ANDA
- Marketing start
- 2020-07-06
- 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 |
|---|
| 0615-8508-05 | Cyclobenzaprine hydrochloride | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 1 |
| 0615-8508-39 | Cyclobenzaprine hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8508 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 2 package rows | 20240614_e332763b-00c6-41bf-84ae-a07d9ef79697.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8508-05 | 00615850805 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-05) | 2024-05-16 | No | No | Current |
| 0615-8508-39 | 00615850839 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-39) | 2024-05-16 | No | No | Current |