NDC 70518-0635

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.

Product ID70518-0635_7df73466-9bca-13ee-e053-2a91aa0a0784
NDC70518-0635
Product TypeHuman Prescription Drug
Proprietary NameCyclobenzaprine Hydrochloride
Generic NameCyclobenzaprine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-07-25
Marketing CategoryANDA / ANDA
Application NumberANDA090478
Labeler NameREMEDYREPACK INC.
Substance NameCYCLOBENZAPRINE
Active Ingredient Strength10 mg/1
Pharm ClassesCentrally-media
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-0635-2

20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0635-2)
Marketing Start Date2017-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0635-6 [70518063506]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-26

NDC 70518-0635-3 [70518063503]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-18

NDC 70518-0635-4 [70518063504]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-27

NDC 70518-0635-7 [70518063507]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-27

NDC 70518-0635-1 [70518063501]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-17

NDC 70518-0635-0 [70518063500]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-25

NDC 70518-0635-2 [70518063502]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-25

NDC 70518-0635-5 [70518063505]

Cyclobenzaprine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-15

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:e9afbbef-5be5-4141-be45-30e1d6e7fa89
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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