NDC 12634-528

Cyclobenzaprine Hydrochloride

Cyclobenzaprine Hydrochloride

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

Product ID12634-528_27fe4bb9-282f-42ca-e054-00144ff88e88
NDC12634-528
Product TypeHuman Prescription Drug
Proprietary NameCyclobenzaprine Hydrochloride
Generic NameCyclobenzaprine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-04-02
Marketing CategoryANDA / ANDA
Application NumberANDA090478
Labeler NameApotheca Inc.
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 12634-528-94

4 TABLET in 1 BOTTLE (12634-528-94)
Marketing Start Date2012-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-528-94 [12634052894]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-74 [12634052874]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-91 [12634052891]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-71 [12634052871]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-81 [12634052881]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-28
Inactivation Date2020-01-31

NDC 12634-528-57 [12634052857]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-85 [12634052885]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-66 [12634052866]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-82 [12634052882]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-69 [12634052869]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-52 [12634052852]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-54 [12634052854]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-80 [12634052880]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-59 [12634052859]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-21 [12634052821]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Marketing End Date2015-12-28

NDC 12634-528-00 [12634052800]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-63 [12634052863]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-60 [12634052860]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-01 [12634052801]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-96 [12634052896]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-67 [12634052867]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-61 [12634052861]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-95 [12634052895]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

NDC 12634-528-78 [12634052878]

Cyclobenzaprine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090478
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:27327397-3ff7-6e43-e054-00144ff88e88
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
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