NDC 33261-033

Cyclobenzaprine Hydrochloride

Cyclobenzaprine Hydrochloride

Cyclobenzaprine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Cyclobenzaprine Hydrochloride.

Product ID33261-033_1b891b2e-c23a-44cf-8d4e-4d26dd070023
NDC33261-033
Product TypeHuman Prescription Drug
Proprietary NameCyclobenzaprine Hydrochloride
Generic NameCyclobenzaprine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-02-18
Marketing CategoryANDA / ANDA
Application NumberANDA078218
Labeler NameAidarex Pharmaceuticals LLC
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 33261-033-40

40 TABLET in 1 BOTTLE, PLASTIC (33261-033-40)
Marketing Start Date2010-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-033-02 [33261003302]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 33261-033-21 [33261003321]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 33261-033-14 [33261003314]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 33261-033-12 [33261003312]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 33261-033-15 [33261003315]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 33261-033-40 [33261003340]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 33261-033-20 [33261003320]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 33261-033-60 [33261003360]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 33261-033-30 [33261003330]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

NDC 33261-033-90 [33261003390]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:c108987e-f1f9-4f0e-893a-fb036af0ce08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828348
  • 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.