Cyclobenzaprine Hydrochloride
- Product NDC
- 59746-735
- 11-digit product format
- 597460735
- Labeler code
- 59746
- Product ID
- 59746-735_a18ba005-b6de-4c5b-a837-489d74022084
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmaceuticals Inc.
- Application
- ANDA077563
- Marketing category
- ANDA
- Marketing start
- 2017-10-09
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 7.5 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828299, 828320, 828348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59746-735-01 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
| 59746-735-10 | Cyclobenzaprine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
| 59746-735-30 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59746-735 | CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250227_592871f6-0eb2-4624-9e10-bd8bf767c002.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 |
|---|
| 59746-735-01 | 59746073501 | 100 TABLET, FILM COATED in 1 BOTTLE (59746-735-01) | 2017-10-09 | 0000-00-00 | No | No | Current |
| 59746-735-10 | 59746073510 | 1000 TABLET, FILM COATED in 1 BOTTLE (59746-735-10) | 2017-10-09 | 0000-00-00 | No | No | Current |
| 59746-735-30 | 59746073530 | 30 TABLET, FILM COATED in 1 BOTTLE (59746-735-30) | 2017-10-09 | 0000-00-00 | No | No | Current |