Cyclobenzaprine Hydrochloride
- Product NDC
- 65862-191
- 11-digit product format
- 658620191
- Labeler code
- 65862
- Product ID
- 65862-191_13f9bb96-7677-4506-befe-d7afa9b13cab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA078643
- Marketing category
- ANDA
- Marketing start
- 2008-09-26
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828320, 828348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-191-01 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
| 65862-191-05 | Cyclobenzaprine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 10 |
| 65862-191-99 | Cyclobenzaprine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 10 |
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 [AUROBINDO PHARMA LIMITED] | 7 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 7 | |
| CYCLOBENZAPRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0VE05JYS2P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-191 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 10 | Current NDC, Legacy NDC, 3 package rows | 20211110_1154688c-1383-442b-a3a5-ec01e038795c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-191-01 | 65862019101 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-191-01) | 2008-09-26 | 0000-00-00 | No | No | Current |
| 65862-191-05 | 65862019105 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-191-05) | 2008-09-26 | 0000-00-00 | No | No | Current |
| 65862-191-81 | 65862019181 | 8000 TABLET, FILM COATED in 1 BAG (65862-191-81) | 26-SEP-08 | | | | Current |
| 65862-191-99 | 65862019199 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-191-99) | 2008-09-26 | 0000-00-00 | No | No | Current |