Cyclobenzaprine Hydrochloride
- Product NDC
- 45865-244
- 11-digit product format
- 458650244
- Labeler code
- 45865
- Product ID
- 45865-244_12645512-7cb8-0532-e063-6294a90acbe5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA078643
- Marketing category
- ANDA
- Marketing start
- 2008-09-26
- 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 |
|---|
| 45865-244-14 | Cyclobenzaprine Hydrochloride | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 1 |
| 45865-244-20 | Cyclobenzaprine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
| 45865-244-30 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 45865-244-60 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 45865-244-90 | Cyclobenzaprine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-244 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | Current NDC, 5 package rows | 20240229_12645f19-fffc-8b08-e063-6394a90a5c55.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 45865-244-14 | 45865024414 | 14 TABLET, FILM COATED in 1 BOTTLE (45865-244-14) | 2023-03-07 | No | No | Current |
| 45865-244-20 | 45865024420 | 20 TABLET, FILM COATED in 1 BOTTLE (45865-244-20) | 2023-07-10 | No | No | Current |
| 45865-244-30 | 45865024430 | 30 TABLET, FILM COATED in 1 BOTTLE (45865-244-30) | 2023-05-23 | No | No | Current |
| 45865-244-60 | 45865024460 | 60 TABLET, FILM COATED in 1 BOTTLE (45865-244-60) | 2023-02-23 | No | No | Current |
| 45865-244-90 | 45865024490 | 90 TABLET, FILM COATED in 1 BOTTLE (45865-244-90) | 2023-02-23 | No | No | Current |