CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 76420-265
- 11-digit product format
- 764200265
- Labeler code
- 76420
- Product ID
- 76420-265_e89c4c80-d10f-2a48-e053-2995a90a5d58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA208170
- Marketing category
- ANDA
- Marketing start
- 2017-05-31
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-265-10 | CYCLOBENZAPRINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 76420-265-30 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 76420-265-60 | CYCLOBENZAPRINE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 76420-265-90 | CYCLOBENZAPRINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-265 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20220919_2a6b2ad9-307a-4976-98b7-1b96e0408da7.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 |
|---|
| 76420-265-10 | 76420026510 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-265-10) | 2022-09-01 | 0000-00-00 | No | No | Current |
| 76420-265-30 | 76420026530 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-265-30) | 2022-09-01 | 0000-00-00 | No | No | Current |
| 76420-265-60 | 76420026560 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-265-60) | 2022-09-01 | 0000-00-00 | No | No | Current |
| 76420-265-90 | 76420026590 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-265-90) | 2022-09-01 | 0000-00-00 | No | No | Current |