CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 76420-011
- 11-digit product format
- 764200011
- Labeler code
- 76420
- Product ID
- 76420-011_4ad5c599-4f5b-6372-e063-6394a90ae881
- 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
- 10 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CYCLOBENZAPRINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
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 |
|---|
| 76420-011-01 | CYCLOBENZAPRINE HYDROCHLORIDE | 1 in 1 BOTTLE | TABLET, FILM COATED | 1 | | 5 |
| 76420-011-02 | CYCLOBENZAPRINE HYDROCHLORIDE | 2 in 1 BOTTLE | TABLET, FILM COATED | 2 | | 5 |
| 76420-011-04 | CYCLOBENZAPRINE HYDROCHLORIDE | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 5 |
| 76420-011-05 | CYCLOBENZAPRINE HYDROCHLORIDE | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 5 |
| 76420-011-07 | CYCLOBENZAPRINE HYDROCHLORIDE | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 5 |
| 76420-011-12 | CYCLOBENZAPRINE HYDROCHLORIDE | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 5 |
| 76420-011-20 | CYCLOBENZAPRINE HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 5 |
| 76420-011-30 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 76420-011-60 | CYCLOBENZAPRINE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
| 76420-011-90 | CYCLOBENZAPRINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-011 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.] | 4 | Current NDC, Legacy NDC, 10 package rows | 20250413_06da53af-5b46-4e32-a64c-9677e27ae229.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 |
|---|
| 76420-011-01 | 76420001101 | 1 TABLET, FILM COATED in 1 BOTTLE (76420-011-01) | 2020-01-23 | 0000-00-00 | No | No | Current |
| 76420-011-02 | 76420001102 | 2 TABLET, FILM COATED in 1 BOTTLE (76420-011-02) | 2020-01-23 | 0000-00-00 | No | No | Current |
| 76420-011-04 | 76420001104 | 4 TABLET, FILM COATED in 1 BOTTLE (76420-011-04) | 2025-04-11 | | No | No | Current |
| 76420-011-05 | 76420001105 | 5 TABLET, FILM COATED in 1 BOTTLE (76420-011-05) | 2024-12-24 | | No | No | Current |
| 76420-011-07 | 76420001107 | 7 TABLET, FILM COATED in 1 BOTTLE (76420-011-07) | 2020-01-23 | 0000-00-00 | No | No | Current |
| 76420-011-12 | 76420001112 | 120 TABLET, FILM COATED in 1 BOTTLE (76420-011-12) | 2025-04-11 | | No | No | Current |
| 76420-011-20 | 76420001120 | 20 TABLET, FILM COATED in 1 BOTTLE (76420-011-20) | 2020-01-23 | 0000-00-00 | No | No | Current |
| 76420-011-30 | 76420001130 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-011-30) | 2020-01-23 | 0000-00-00 | No | No | Current |
| 76420-011-60 | 76420001160 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-011-60) | 2020-01-23 | 0000-00-00 | No | No | Current |
| 76420-011-90 | 76420001190 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-011-90) | 2022-08-10 | 0000-00-00 | No | No | Current |