NDC 42254-239

CYCLOBENZAPRINE HYROCHLORIDE

Cyclobenzaprine Hydrochloride

CYCLOBENZAPRINE HYROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Cyclobenzaprine Hydrochloride.

Product ID42254-239_92f5c528-e1af-4268-9f5f-ae5558a5104c
NDC42254-239
Product TypeHuman Prescription Drug
Proprietary NameCYCLOBENZAPRINE HYROCHLORIDE
Generic NameCyclobenzaprine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-08-29
Marketing CategoryANDA / ANDA
Application NumberANDA078722
Labeler NameRebel Distributors Corp
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 42254-239-60

60 TABLET in 1 BOTTLE (42254-239-60)
Marketing Start Date2011-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42254-239-30 [42254023930]

CYCLOBENZAPRINE HYROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA078722
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-08-29
Inactivation Date2019-09-24

NDC 42254-239-60 [42254023960]

CYCLOBENZAPRINE HYROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA078722
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-08-29
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE7.5 mg/1

OpenFDA Data

SPL SET ID:92f5c528-e1af-4268-9f5f-ae5558a5104c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828299

    • Pharmacological Class

    • Centrally-mediated Muscle Relaxation [PE]
    • Muscle Relaxant [EPC]

    NDC Crossover Matching brand name "CYCLOBENZAPRINE HYROCHLORIDE" or generic name "Cyclobenzaprine Hydrochloride"

    NDCBrand NameGeneric Name
    76519-1000CYCLOBENZAPRINE HYROCHLORIDECYCLOBENZAPRINE HYROCHLORIDE
    42254-239CYCLOBENZAPRINE HYROCHLORIDECYCLOBENZAPRINE HYROCHLORIDE
    63629-4664CYCLOBENZAPRINE HYROCHLORIDECYCLOBENZAPRINE HYROCHLORIDE
    0093-1920Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0093-1921Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0093-3420Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0093-3421Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0093-3422Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0115-1436Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0115-1437Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0179-0057cyclobenzaprine hydrochloridecyclobenzaprine hydrochloride
    0179-0189cyclobenzaprine hydrochloridecyclobenzaprine hydrochloride
    0378-0751Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
    0378-0761Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
    0378-0771Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
    0440-1350Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0440-7350Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0591-3256Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0591-3330Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0591-5658Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0615-3520Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
    0615-7528Cyclobenzaprine Hydrochloridecyclobenzaprine hydrochloride
    0615-8182Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0904-7809Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.