NDC 70518-0082

Cyclobenzaprine Hydrochloride

Cyclobenzaprine

Cyclobenzaprine Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Cyclobenzaprine Hydrochloride.

Product ID70518-0082_80353e0c-9296-8300-e053-2991aa0abffd
NDC70518-0082
Product TypeHuman Prescription Drug
Proprietary NameCyclobenzaprine Hydrochloride
Generic NameCyclobenzaprine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-12-23
Marketing CategoryANDA / ANDA
Application NumberANDA090478
Labeler NameREMEDYREPACK INC.
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0082-1

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0082-1)
Marketing Start Date2017-01-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0082-4 [70518008204]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-05
Marketing End Date2020-04-16

NDC 70518-0082-2 [70518008202]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-03

NDC 70518-0082-1 [70518008201]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-11

NDC 70518-0082-0 [70518008200]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-23
Marketing End Date2020-04-16

NDC 70518-0082-3 [70518008203]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-19

NDC 70518-0082-6 [70518008206]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-09
Marketing End Date2020-04-16

NDC 70518-0082-5 [70518008205]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-12

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:58c36a05-35b1-4cac-af71-cd5513a10a8f
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"

    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
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