Cyclobenzaprine Hydrochloride
- Product NDC
- 0615-8084
- 11-digit product format
- 006158084
- Labeler code
- 0615
- Product ID
- 0615-8084_3af92905-fa00-41fa-9156-037f58b21a0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA090478
- Marketing category
- ANDA
- Marketing start
- 2016-07-22
- 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 |
|---|
| 0615-8084-05 | Cyclobenzaprine Hydrochloride | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 6 |
| 0615-8084-30 | Cyclobenzaprine Hydrochloride | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 6 |
| 0615-8084-30 | Cyclobenzaprine Hydrochloride | 6 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 6 | | 6 |
| 0615-8084-39 | Cyclobenzaprine Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8084 | CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240815_53688de9-2031-4d19-b422-4000285f7f47.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8084-05 | 00615808405 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8084-05) | | 2016-07-22 | 0000-00-00 | No | No | Current |
| 0615-8084-30 | 00615808430 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8084-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK | 6 blister pack | 2016-07-22 | 0000-00-00 | No | No | Current |
| 0615-8084-39 | 00615808439 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8084-39) | | 2016-07-22 | 0000-00-00 | No | No | Current |