Cyclobenzaprine Hydrochloride
- Product NDC
- 68071-3154
- 11-digit product format
- 680713154
- Labeler code
- 68071
- Product ID
- 68071-3154_522f6658-ed23-f634-e063-6294a90af0fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA090478
- Marketing category
- ANDA
- Marketing start
- 2016-07-22
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3154-1 | Cyclobenzaprine Hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 5 |
| 68071-3154-3 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 68071-3154-6 | Cyclobenzaprine Hydrochloride | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 5 |
| 68071-3154-7 | Cyclobenzaprine Hydrochloride | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 5 |
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 |
|---|
| 68071-3154-1 | 68071315401 | 10 TABLET, FILM COATED in 1 BOTTLE (68071-3154-1) | 2017-05-17 | 0000-00-00 | No | No | Current |
| 68071-3154-3 | 68071315403 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3154-3) | 2017-05-17 | 0000-00-00 | No | No | Current |
| 68071-3154-6 | 68071315406 | 6 TABLET, FILM COATED in 1 BOTTLE (68071-3154-6) | 2017-05-17 | 0000-00-00 | No | No | Current |
| 68071-3154-7 | 68071315407 | 7 TABLET, FILM COATED in 1 BOTTLE (68071-3154-7) | 2017-05-17 | 0000-00-00 | No | No | Current |