Cyclobenzaprine hydrochloride
- Product NDC
- 67296-1441
- 11-digit product format
- 672961441
- Labeler code
- 67296
- Product ID
- 67296-1441_2c6228e2-dbac-01e7-e063-6394a90acbbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Redpharm Drug, Inc.
- Application
- ANDA213324
- Marketing category
- ANDA
- Marketing start
- 2020-07-06
- 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 | 828348 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67296-1441-1 | Cyclobenzaprine hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 2 |
| 67296-1441-2 | Cyclobenzaprine hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
| 67296-1441-3 | Cyclobenzaprine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 67296-1441-7 | Cyclobenzaprine hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 67296-1441-8 | Cyclobenzaprine hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-1441 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.] | 2 | Current NDC, 1 package rows | 20250124_09d0e2fc-76a4-bb7d-e063-6394a90a4a7d.zip |
| 67296-1441 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.] | 1 | Current NDC, 4 package rows | 20230205_f3d20bc8-ca02-11f5-e053-2995a90a720a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67296-1441-1 | 67296144101 | 10 TABLET, FILM COATED in 1 BOTTLE (67296-1441-1) | 2020-07-06 | No | No | Current |
| 67296-1441-2 | 67296144102 | 20 in 1 BOTTLE | | | | Historical |
| 67296-1441-3 | 67296144103 | 30 in 1 BOTTLE | | | | Historical |
| 67296-1441-7 | 67296144107 | 15 in 1 BOTTLE | | | | Historical |
| 67296-1441-8 | 67296144108 | 10 in 1 BOTTLE | | | | Historical |