CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 52959-846
- 11-digit product format
- 529590846
- Labeler code
- 52959
- Product ID
- 52959-846_5f8ab159-7b81-b3f2-e053-2a91aa0ae2d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CYCLOBENZAPRINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- H. J. Harkins Company Inc.
- Application
- ANDA078048
- Marketing category
- ANDA
- Marketing start
- 2017-01-03
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 52959-846-30 | Therabenzaprine-90-5 | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 5 mg | 7 |
| 52959-846-00 | CYCLOBENZAPRINE HYDROCHLORIDE | 100 in 1 CONTAINER | TABLET, FILM COATED | 100 | | 1 |
| 52959-846-02 | CYCLOBENZAPRINE HYDROCHLORIDE | 120 in 1 CONTAINER | TABLET, FILM COATED | 120 | | 1 |
| 52959-846-10 | CYCLOBENZAPRINE HYDROCHLORIDE | 10 in 1 CONTAINER | TABLET, FILM COATED | 10 | | 1 |
| 52959-846-15 | CYCLOBENZAPRINE HYDROCHLORIDE | 15 in 1 CONTAINER | TABLET, FILM COATED | 15 | | 1 |
| 52959-846-20 | CYCLOBENZAPRINE HYDROCHLORIDE | 20 in 1 CONTAINER | TABLET, FILM COATED | 20 | | 1 |
| 52959-846-30 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 52959-846-40 | CYCLOBENZAPRINE HYDROCHLORIDE | 40 in 1 CONTAINER | TABLET, FILM COATED | 40 | | 1 |
| 52959-846-60 | CYCLOBENZAPRINE HYDROCHLORIDE | 60 in 1 CONTAINER | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| .GAMMA.-AMINOBUTYRIC ACID | ACTIVE INGREDIENT | 2ACZ6IPC6I | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| CYCLOBENZAPRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0VE05JYS2P | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| .GAMMA.-AMINOBUTYRIC ACID | ACTIVE MOIETY | 2ACZ6IPC6I | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-846 | THERABENZAPRINE-90-5 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 7 | Legacy NDC | 20110815_91356085-a6d8-4a41-8197-785fc21fb9de.zip |
| 52959-846 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [H. J. HARKINS COMPANY INC.] | 1 | Legacy NDC, 8 package rows | 20171207_5f8ab159-7b80-b3f2-e053-2a91aa0ae2d7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-846-00 | 52959084600 | 100 in 1 CONTAINER | Historical |
| 52959-846-02 | 52959084602 | 120 in 1 CONTAINER | Historical |
| 52959-846-10 | 52959084610 | 10 in 1 CONTAINER | Historical |
| 52959-846-15 | 52959084615 | 15 in 1 CONTAINER | Historical |
| 52959-846-20 | 52959084620 | 20 in 1 CONTAINER | Historical |
| 52959-846-30 | 52959084630 | 30 in 1 BOTTLE | Historical |
| 52959-846-40 | 52959084640 | 40 in 1 CONTAINER | Historical |
| 52959-846-60 | 52959084660 | 60 in 1 CONTAINER | Historical |