CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 53746-540
- 11-digit product format
- 537460540
- Labeler code
- 53746
- Product ID
- 53746-540_b0e32570-da9f-4fa8-a0a2-0334fce7ff7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CYCLOBENZAPRINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA078218
- Marketing category
- ANDA
- Marketing start
- 2010-02-18
- 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, 828348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-540-01 | CYCLOBENZAPRINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
| 53746-540-05 | CYCLOBENZAPRINE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 6 |
| 53746-540-10 | CYCLOBENZAPRINE HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-540 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240101_31bb92f6-ec8c-4636-8b07-8814417fe78e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53746-540-01 | 53746054001 | 100 TABLET, FILM COATED in 1 BOTTLE (53746-540-01) | 2010-02-18 | 0000-00-00 | No | No | Current |
| 53746-540-05 | 53746054005 | 500 TABLET, FILM COATED in 1 BOTTLE (53746-540-05) | 2010-02-18 | 0000-00-00 | No | No | Current |
| 53746-540-10 | 53746054010 | 1000 TABLET, FILM COATED in 1 BOTTLE (53746-540-10) | 2010-02-18 | 0000-00-00 | No | No | Current |