Cyclobenzaprine Hydrochloride
- Product NDC
- 68788-9967
- 11-digit product format
- 687889967
- Labeler code
- 68788
- Product ID
- 68788-9967_e381786e-1a5f-4d43-b7d1-3abc16c3dec3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2015-05-01
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 7.5 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828299 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-9967-1 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 12 |
| 68788-9967-2 | Cyclobenzaprine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 12 |
| 68788-9967-3 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
| 68788-9967-6 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 12 |
| 68788-9967-7 | Cyclobenzaprine Hydrochloride | 8 in 1 BOTTLE | TABLET, FILM COATED | 8 | | 12 |
| 68788-9967-8 | Cyclobenzaprine Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 12 |
| 68788-9967-9 | Cyclobenzaprine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0VE05JYS2P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9967 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 7 package rows | 20250315_a4cc7965-2ba8-42e8-8c5c-b90145a6598a.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 |
|---|
| 68788-9967-1 | 68788996701 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-9967-1) | 2015-05-01 | 0000-00-00 | No | No | Current |
| 68788-9967-2 | 68788996702 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-9967-2) | 2015-05-01 | 0000-00-00 | No | No | Current |
| 68788-9967-3 | 68788996703 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-9967-3) | 2015-05-01 | 0000-00-00 | No | No | Current |
| 68788-9967-6 | 68788996706 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-9967-6) | 2015-05-01 | 0000-00-00 | No | No | Current |
| 68788-9967-7 | 68788996707 | 8 TABLET, FILM COATED in 1 BOTTLE (68788-9967-7) | 2019-08-14 | 0000-00-00 | No | No | Current |
| 68788-9967-8 | 68788996708 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-9967-8) | 2015-05-01 | 0000-00-00 | No | No | Current |
| 68788-9967-9 | 68788996709 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-9967-9) | 2015-05-01 | 0000-00-00 | No | No | Current |