NDC 63459-700

AMRIX

Cyclobenzaprine Hydrochloride

AMRIX is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Llc. The primary component is Cyclobenzaprine Hydrochloride.

Product ID63459-700_3c2e7f28-5a71-4c19-8173-9c3ed6e7a9a2
NDC63459-700
Product TypeHuman Prescription Drug
Proprietary NameAMRIX
Generic NameCyclobenzaprine Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2007-10-02
Marketing CategoryNDA / NDA
Application NumberNDA021777
Labeler NameCephalon, LLC
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength15 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63459-700-60

60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63459-700-60)
Marketing Start Date2007-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63459-700-15 [63459070015]

AMRIX CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021777
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-02
Marketing End Date2015-05-31

NDC 63459-700-11 [63459070011]

AMRIX CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021777
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-02

NDC 63459-700-22 [63459070022]

AMRIX CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021777
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-02
Marketing End Date2018-10-31

NDC 63459-700-02 [63459070002]

AMRIX CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021777
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-05

NDC 63459-700-60 [63459070060]

AMRIX CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021777
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-02

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE15 mg/1

OpenFDA Data

SPL SET ID:3902123b-1365-ac3c-0934-afff9eeeb1bd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828355
  • 828358
  • 828359
  • 828353

    • Pharmacological Class

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

    Medicade Reported Pricing

    63459070060 AMRIX ER 15 MG CAPSULE

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    21695-723AMRIXAMRIX
    21695-953AMRIXAMRIX
    35356-262AmrixAmrix
    50090-1101AMRIXAMRIX
    63459-700AMRIXAMRIX
    63459-701AMRIXAMRIX
    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 [AMRIX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AMRIX
    AMRIX
    78261264 3353178 Live/Registered
    TEVA PHARMACEUTICALS INTERNATIONAL GMBH
    2003-06-11
    AMRIX
    AMRIX
    77307173 3684884 Live/Registered
    TEVA PHARMACEUTICALS INTERNATIONAL GMBH
    2007-10-18
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