Cyclobenzaprine Hydrochloride
- Product NDC
- 63304-214
- 11-digit product format
- 633040214
- Labeler code
- 63304
- Product ID
- 63304-214_510b79b4-038e-4df6-96ee-c519457f50bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ranbaxy Pharmaceuticals Inc
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2008-05-12
- 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 |
|---|
| 63304-214-10 | Cyclobenzaprine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
| 63304-214-30 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 63304-214-69 | Cyclobenzaprine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 2 |
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 [RANBAXY PHARMACEUTICALS INC] | 2 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-214 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC] | 2 | Legacy NDC, 3 package rows | 20130729_fa8ea64a-62e7-4bbc-a4d3-4fee53cf21c7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 63304-214-10 | 63304021410 | 1000 in 1 BOTTLE | Historical |
| 63304-214-30 | 63304021430 | 30 in 1 BOTTLE | Historical |
| 63304-214-69 | 63304021469 | 10 in 1 BLISTER PACK | Historical |