Cyclobenzaprine Hydrochloride
- Product NDC
- 43063-516
- 11-digit product format
- 430630516
- Labeler code
- 43063
- Product ID
- 43063-516_e6899f9a-9e1e-126b-e053-2a95a90a5fc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078048
- Marketing category
- ANDA
- Marketing start
- 2014-07-31
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
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 [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-516 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 23 | Legacy NDC | 20241013_72031488-c339-48e1-8299-db7e5ad0c6f3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-516-01 | 43063051601 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-01) | 2018-12-13 | 0000-00-00 | No | No | Current |
| 43063-516-03 | 43063051603 | 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-03) | 2014-07-31 | 0000-00-00 | No | No | Current |
| 43063-516-04 | 43063051604 | 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-04) | 2014-07-31 | 0000-00-00 | No | No | Current |
| 43063-516-06 | 43063051606 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-06) | 2014-07-31 | 0000-00-00 | No | No | Current |
| 43063-516-09 | 43063051609 | 9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-09) | 2015-01-15 | 0000-00-00 | No | No | Current |
| 43063-516-10 | 43063051610 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-10) | 2014-07-31 | 0000-00-00 | No | No | Current |
| 43063-516-12 | 43063051612 | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-12) | 2015-01-27 | 0000-00-00 | No | No | Current |
| 43063-516-14 | 43063051614 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-14) | 2014-07-31 | 0000-00-00 | No | No | Current |
| 43063-516-15 | 43063051615 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-15) | 2014-07-31 | 0000-00-00 | No | No | Current |
| 43063-516-20 | 43063051620 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-20) | 2014-07-31 | 0000-00-00 | No | No | Current |
| 43063-516-21 | 43063051621 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-21) | 2014-07-31 | 0000-00-00 | No | No | Current |
| 43063-516-30 | 43063051630 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-30) | 2014-07-31 | 0000-00-00 | No | No | Current |
| 43063-516-40 | 43063051640 | 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-40) | 2017-01-06 | 0000-00-00 | No | No | Current |
| 43063-516-42 | 43063051642 | 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-42) | 2014-09-17 | 0000-00-00 | No | No | Current |
| 43063-516-60 | 43063051660 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-60) | 2014-09-19 | 0000-00-00 | No | No | Current |
| 43063-516-82 | 43063051682 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-82) | 2018-12-13 | 0000-00-00 | No | No | Current |
| 43063-516-90 | 43063051690 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-90) | 2014-08-08 | 0000-00-00 | No | No | Current |
| 43063-516-95 | 43063051695 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-516-95) | 2018-12-13 | 0000-00-00 | No | No | Current |