NDC 76519-1000

CYCLOBENZAPRINE HYROCHLORIDE

Cyclobenzaprine Hydrochloride

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

Product ID76519-1000_1987e93d-951f-4738-af92-6196f753d121
NDC76519-1000
Product TypeHuman Prescription Drug
Proprietary NameCYCLOBENZAPRINE HYROCHLORIDE
Generic NameCyclobenzaprine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-08-29
Marketing CategoryANDA / ANDA
Application NumberANDA078722
Labeler NameH.J. Harkins Company, Inc.
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 76519-1000-7

120 TABLET in 1 BOTTLE (76519-1000-7)
Marketing Start Date2011-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1000-7 [76519100007]

CYCLOBENZAPRINE HYROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA078722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-29
Inactivation Date2019-11-13

NDC 76519-1000-3 [76519100003]

CYCLOBENZAPRINE HYROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA078722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-29
Inactivation Date2019-11-13

NDC 76519-1000-5 [76519100005]

CYCLOBENZAPRINE HYROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA078722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-29
Inactivation Date2019-11-13

NDC 76519-1000-9 [76519100009]

CYCLOBENZAPRINE HYROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA078722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-29
Inactivation Date2019-11-13

NDC 76519-1000-2 [76519100002]

CYCLOBENZAPRINE HYROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA078722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-29
Inactivation Date2019-11-13

NDC 76519-1000-6 [76519100006]

CYCLOBENZAPRINE HYROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA078722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-29
Inactivation Date2019-11-13

NDC 76519-1000-1 [76519100001]

CYCLOBENZAPRINE HYROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA078722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-29
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE7.5 mg/1

OpenFDA Data

SPL SET ID:884b2f1f-ba7c-4218-b7b8-d4bd3f56482e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828299

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    76519-1000CYCLOBENZAPRINE HYROCHLORIDECYCLOBENZAPRINE HYROCHLORIDE
    42254-239CYCLOBENZAPRINE HYROCHLORIDECYCLOBENZAPRINE HYROCHLORIDE
    63629-4664CYCLOBENZAPRINE HYROCHLORIDECYCLOBENZAPRINE HYROCHLORIDE
    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
    0615-8182Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
    0904-7809Cyclobenzaprine HydrochlorideCyclobenzaprine Hydrochloride
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