NDC 35356-262

Amrix

Cyclobenzaprine Hydrochloride

Amrix is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Cyclobenzaprine Hydrochloride.

Product ID35356-262_23bf2785-8ee7-4c37-a4d8-dc520b107602
NDC35356-262
Product TypeHuman Prescription Drug
Proprietary NameAmrix
Generic NameCyclobenzaprine Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-01-03
Marketing CategoryNDA / NDA
Application NumberNDA021777
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Active Ingredient Strength15 mg/1
Pharm ClassesCentrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-262-60

60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (35356-262-60)
Marketing Start Date2012-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-262-60 [35356026260]

Amrix CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021777
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-03
Marketing End Date2019-10-11

NDC 35356-262-30 [35356026230]

Amrix CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021777
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-03
Marketing End Date2017-01-01

NDC 35356-262-10 [35356026210]

Amrix CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021777
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-03
Marketing End Date2017-01-01

Drug Details

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE15 mg/1

OpenFDA Data

SPL SET ID:67c46f2e-59fe-4c20-a07d-79935d496d1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 828358
  • 828359

    • 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
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