NDC 53149-4842

Cyclobenzaprine

Cyclobenzaprine Hydrochloride

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

Product ID53149-4842_a5d66602-d6fb-47a6-9bb7-6640e5b56555
NDC53149-4842
Product TypeHuman Prescription Drug
Proprietary NameCyclobenzaprine
Generic NameCyclobenzaprine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-10-18
Marketing CategoryANDA / ANDA
Application NumberANDA071611
Labeler NameAll Pharma, LLC
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 53149-4842-9

90 TABLET, FILM COATED in 1 BOTTLE (53149-4842-9)
Marketing Start Date2018-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53149-4842-6 [53149484206]

Cyclobenzaprine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA071611
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-07
Inactivation Date2020-01-31

NDC 53149-4842-3 [53149484203]

Cyclobenzaprine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA071611
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-07
Inactivation Date2020-01-31

NDC 53149-4842-1 [53149484201]

Cyclobenzaprine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA071611
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-07
Inactivation Date2020-01-31

NDC 53149-4842-9 [53149484209]

Cyclobenzaprine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA071611
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE7.5 mg/1

OpenFDA Data

SPL SET ID:f40e92bb-c86b-4634-9bba-9fa4616aba82
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828299

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    53149-4842CyclobenzaprineCyclobenzaprine
    57237-266CyclobenzaprineCyclobenzaprine
    61919-305CYCLOBENZAPRINECYCLOBENZAPRINE
    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
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