NDC 52959-846

CYCLOBENZAPRINE HYDROCHLORIDE

Cyclobenzaprine Hydrochloride

CYCLOBENZAPRINE HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by H. J. Harkins Company Inc.. The primary component is Cyclobenzaprine Hydrochloride.

Product ID52959-846_5f8ab159-7b81-b3f2-e053-2a91aa0ae2d7
NDC52959-846
Product TypeHuman Prescription Drug
Proprietary NameCYCLOBENZAPRINE HYDROCHLORIDE
Generic NameCyclobenzaprine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA078048
Labeler NameH. J. Harkins Company Inc.
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52959-846-20

20 TABLET, FILM COATED in 1 CONTAINER (52959-846-20)
Marketing Start Date2017-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-846-40 [52959084640]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-846-00 [52959084600]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-846-60 [52959084660]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-846-15 [52959084615]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-846-02 [52959084602]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-846-20 [52959084620]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-846-10 [52959084610]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-846-30 [52959084630]

CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:5f8ab159-7b80-b3f2-e053-2a91aa0ae2d7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828320

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    0615-8084Cyclobenzaprine HydrochlorideCyclobenzaprine
    0615-8182Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-3149Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-1983Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-1961Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-1998Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-3154Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-3377Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-3150Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-3390Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-4076Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-4415Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride
    68071-4502Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68071-4655CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE
    68071-4826Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68084-753Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68258-7150CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE
    68258-7013Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68387-500Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68387-502Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68645-518Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68645-517Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-6375Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-7398Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-9069Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-7131Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-9508Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-9295Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    68788-9967Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    69097-846Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    69097-845Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.