Cyclobenzaprine Hydrochloride
- Product NDC
- 64980-655
- 11-digit product format
- 649800655
- Labeler code
- 64980
- Product ID
- 64980-655_0512aebe-5f3a-4d41-9a41-7c37e001af75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA218936
- Marketing category
- ANDA
- Marketing start
- 2025-02-19
- 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 |
|---|
| 64980-655-01 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 64980-655-10 | Cyclobenzaprine Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
| 64980-655-50 | Cyclobenzaprine Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-655 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 3 package rows | 20250223_6018b6e9-938d-4fc9-86d7-1fd1d7bfcc58.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64980-655-01 | 64980065501 | 100 TABLET in 1 BOTTLE (64980-655-01) | 100 tablet | 2025-02-19 | No | No | Current |
| 64980-655-10 | 64980065510 | 1000 TABLET in 1 BOTTLE (64980-655-10) | 1000 tablet | 2025-02-19 | No | No | Current |
| 64980-655-50 | 64980065550 | 500 TABLET in 1 BOTTLE (64980-655-50) | 500 tablet | 2025-02-19 | No | No | Current |