CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 62332-647
- 11-digit product format
- 623320647
- Labeler code
- 62332
- Product ID
- 62332-647_56acaace-062b-48f0-a75d-db44bf35120d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CYCLOBENZAPRINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA078218
- Marketing category
- ANDA
- Marketing start
- 2010-02-18
- 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 | 828299, 828320, 828348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-647-31 | CYCLOBENZAPRINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 62332-647-71 | CYCLOBENZAPRINE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 62332-647-91 | CYCLOBENZAPRINE HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-647 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20211124_3cdde96c-9fc9-4698-872a-25c05318ecb5.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 |
|---|
| 62332-647-31 | 62332064731 | 100 TABLET, FILM COATED in 1 BOTTLE (62332-647-31) | 2010-02-18 | 0000-00-00 | No | No | Current |
| 62332-647-71 | 62332064771 | 500 TABLET, FILM COATED in 1 BOTTLE (62332-647-71) | 2010-02-18 | 0000-00-00 | No | No | Current |
| 62332-647-91 | 62332064791 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-647-91) | 2010-02-18 | 0000-00-00 | No | No | Current |