Cyclobenzaprine Hydrochloride
- Product NDC
- 55154-0190
- 11-digit product format
- 551540190
- Labeler code
- 55154
- Product ID
- 55154-0190_dc4863e3-5429-453f-8b4d-e639558cb8b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA078643
- Marketing category
- ANDA
- Marketing start
- 2025-10-10
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 55154-0190-0 | Cyclobenzaprine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 2 |
| 55154-0190-0 | Cyclobenzaprine Hydrochloride | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55154-0190-0 | 55154019000 | 10 BLISTER PACK in 1 BAG (55154-0190-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2025-10-10 | No | No | Current |