CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 58517-080
- 11-digit product format
- 585170080
- Labeler code
- 58517
- Product ID
- 58517-080_e8799c4d-1d81-4e78-a29e-01b54c576d09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CYCLOBENZAPRINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- New Horizon Rx Group, LLC
- Application
- ANDA078218
- Marketing category
- ANDA
- Marketing start
- 2013-08-25
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 58517-080-30 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0VE05JYS2P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58517-080 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NEW HORIZON RX GROUP, LLC] | 4 | Legacy NDC, 1 package rows | 20140102_dcd0bfcd-9625-4712-9c43-37b533aea7bb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 58517-080-30 | 58517008030 | 30 in 1 BOTTLE | Historical |