Cyclobenzaprine Hydrochloride
- Product NDC
- 52959-042
- 11-digit product format
- 529590042
- Labeler code
- 52959
- Product ID
- 52959-042_5da7b877-db35-d9af-e053-2a91aa0aa7a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- H. J Harkins Company Inc
- Application
- ANDA077797
- Marketing category
- ANDA
- Marketing start
- 2017-01-03
- Marketing end
- 0000-00-00
- 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
- 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 |
|---|
| 52959-042-60 | Therabenzaprine-90 | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 10 mg | 9 |
| 52959-042-60 | Therabenzaprine-60 | 60 in 1 BOTTLE | TABLET | 60 | 10 mg | 4 |
| 52959-042-00 | Cyclobenzaprine Hydrochloride | 100 in 1 CONTAINER | TABLET, FILM COATED | 100 | | 1 |
| 52959-042-06 | Cyclobenzaprine Hydrochloride | 6 in 1 CONTAINER | TABLET, FILM COATED | 6 | | 1 |
| 52959-042-10 | Cyclobenzaprine Hydrochloride | 10 in 1 CONTAINER | TABLET, FILM COATED | 10 | | 1 |
| 52959-042-15 | Cyclobenzaprine Hydrochloride | 15 in 1 CONTAINER | TABLET, FILM COATED | 15 | | 1 |
| 52959-042-20 | Cyclobenzaprine Hydrochloride | 20 in 1 CONTAINER | TABLET, FILM COATED | 20 | | 1 |
| 52959-042-21 | Cyclobenzaprine Hydrochloride | 21 in 1 CONTAINER | TABLET, FILM COATED | 21 | | 1 |
| 52959-042-30 | Cyclobenzaprine Hydrochloride | 30 in 1 CONTAINER | TABLET, FILM COATED | 30 | | 1 |
| 52959-042-60 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 52959-042-90 | Cyclobenzaprine Hydrochloride | 90 in 1 CONTAINER | TABLET, FILM COATED | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| .GAMMA.-AMINOBUTYRIC ACID | ACTIVE INGREDIENT | 2ACZ6IPC6I | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| CYCLOBENZAPRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0VE05JYS2P | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| .GAMMA.-AMINOBUTYRIC ACID | ACTIVE MOIETY | 2ACZ6IPC6I | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | |
| .GAMMA.-AMINOBUTYRIC ACID | ACTIVE INGREDIENT | 2ACZ6IPC6I | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| CYCLOBENZAPRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0VE05JYS2P | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| .GAMMA.-AMINOBUTYRIC ACID | ACTIVE MOIETY | 2ACZ6IPC6I | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
| TRICALCIUM PHOSPHATE | INACTIVE INGREDIENT | K4C08XP666 | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-042 | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | Legacy NDC | 20110815_6f49de96-1090-46bc-b7bf-0dc70f7d9530.zip |
| 52959-042 | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | Legacy NDC | 20110812_b016f51f-82c2-498d-83f1-51e01505a0ae.zip |
| 52959-042 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [H. J HARKINS COMPANY INC] | 1 | Legacy NDC, 9 package rows | 20171114_5da7b877-db34-d9af-e053-2a91aa0aa7a0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-042-00 | 52959004200 | 100 in 1 CONTAINER | Historical |
| 52959-042-06 | 52959004206 | 6 in 1 CONTAINER | Historical |
| 52959-042-10 | 52959004210 | 10 in 1 CONTAINER | Historical |
| 52959-042-15 | 52959004215 | 15 in 1 CONTAINER | Historical |
| 52959-042-20 | 52959004220 | 20 in 1 CONTAINER | Historical |
| 52959-042-21 | 52959004221 | 21 in 1 CONTAINER | Historical |
| 52959-042-30 | 52959004230 | 30 in 1 CONTAINER | Historical |
| 52959-042-60 | 52959004260 | 60 in 1 BOTTLE | Historical |
| 52959-042-90 | 52959004290 | 90 in 1 CONTAINER | Historical |