Cyclobenzaprine Hydrochloride
- Product NDC
- 68071-3150
- 11-digit product format
- 680713150
- Labeler code
- 68071
- Product ID
- 68071-3150_51171bd5-4e45-8084-e063-6294a90a6f71
- 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 |
|---|
| 68071-3150-1 | Cyclobenzaprine Hydrochloride | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 7 |
| 68071-3150-2 | Cyclobenzaprine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 7 |
| 68071-3150-3 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 68071-3150-4 | Cyclobenzaprine Hydrochloride | 84 in 1 BOTTLE | TABLET, FILM COATED | 84 | | 7 |
| 68071-3150-5 | Cyclobenzaprine Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 7 |
| 68071-3150-6 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 7 |
| 68071-3150-7 | Cyclobenzaprine Hydrochloride | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 7 |
| 68071-3150-8 | Cyclobenzaprine Hydrochloride | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 7 |
| 68071-3150-9 | Cyclobenzaprine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 7 |
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 |
|---|
| 68071-3150-1 | 68071315001 | 21 TABLET, FILM COATED in 1 BOTTLE (68071-3150-1) | 2017-03-07 | 0000-00-00 | No | No | Current |
| 68071-3150-2 | 68071315002 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-3150-2) | 2017-03-07 | 0000-00-00 | No | No | Current |
| 68071-3150-3 | 68071315003 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3150-3) | 2017-03-07 | 0000-00-00 | No | No | Current |
| 68071-3150-4 | 68071315004 | 84 TABLET, FILM COATED in 1 BOTTLE (68071-3150-4) | 2017-03-16 | 0000-00-00 | No | No | Current |
| 68071-3150-5 | 68071315005 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3150-5) | 2017-03-07 | 0000-00-00 | No | No | Current |
| 68071-3150-6 | 68071315006 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3150-6) | 2017-03-07 | 0000-00-00 | No | No | Current |
| 68071-3150-7 | 68071315007 | 7 TABLET, FILM COATED in 1 BOTTLE (68071-3150-7) | 2017-03-07 | 0000-00-00 | No | No | Current |
| 68071-3150-8 | 68071315008 | 6 TABLET, FILM COATED in 1 BOTTLE (68071-3150-8) | 2017-03-07 | 0000-00-00 | No | No | Current |
| 68071-3150-9 | 68071315009 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3150-9) | 2017-03-07 | 0000-00-00 | No | No | Current |