NDC 50436-0950

Fexmid

Cyclobenzaprine Hydrochloride

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

Product ID50436-0950_7175311c-a773-40ac-80df-cc71fed6f2a2
NDC50436-0950
Product TypeHuman Prescription Drug
Proprietary NameFexmid
Generic NameCyclobenzaprine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA071611
Labeler NameUnit Dose Services
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50436-0950-4

120 TABLET, FILM COATED in 1 BOTTLE (50436-0950-4)
Marketing Start Date2017-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50436-0950-3 [50436095003]

Fexmid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA071611
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-15
Inactivation Date2020-01-31

NDC 50436-0950-2 [50436095002]

Fexmid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA071611
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-15
Inactivation Date2020-01-31

NDC 50436-0950-4 [50436095004]

Fexmid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA071611
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-15
Inactivation Date2020-01-31

NDC 50436-0950-1 [50436095001]

Fexmid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA071611
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE7.5 mg/1

OpenFDA Data

SPL SET ID:a948b6b2-ced1-4f7a-a098-2c2e369c3ce3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828299
  • 828301
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Fexmid" or generic name "Cyclobenzaprine Hydrochloride"

    NDCBrand NameGeneric Name
    70199-014FexmidFexmid
    71205-059FexmidFexmid
    21695-830FexmidFexmid
    50436-0950FexmidFexmid
    53149-4851FexmidFexmid
    53149-4850FexmidFexmid
    55700-726FexmidFexmid
    63629-7803FexmidFexmid
    71335-1253FexmidFexmid
    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

    Trademark Results [Fexmid]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FEXMID
    FEXMID
    78957905 3327963 Live/Registered
    CASPER PHARMA LLC
    2006-08-22

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