NDC 21695-953

AMRIX

Cyclobenzaprine Hydrochloride

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

Product ID21695-953_087ae128-1a5d-406e-8bd3-15cb640f6922
NDC21695-953
Product TypeHuman Prescription Drug
Proprietary NameAMRIX
Generic NameCyclobenzaprine Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2007-10-01
Marketing CategoryNDA / NDA
Application NumberNDA021777
Labeler NameRebel Distributors Corp
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength30 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-953-60

60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-953-60)
Marketing Start Date2007-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-953-60 [21695095360]

AMRIX CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021777
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-01
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:087ae128-1a5d-406e-8bd3-15cb640f6922
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828355
  • 828353

    • Pharmacological Class

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

    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.