NDC 0039-0223

AMARYL

Glimepiride

AMARYL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Glimepiride.

Product ID0039-0223_365c68ef-4b6a-4c61-b6b3-96dd9c9a384b
NDC0039-0223
Product TypeHuman Prescription Drug
Proprietary NameAMARYL
Generic NameGlimepiride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-06-18
Marketing CategoryNDA / NDA
Application NumberNDA020496
Labeler NameSanofi-Aventis U.S. LLC
Substance NameGLIMEPIRIDE
Active Ingredient Strength4 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0039-0223-10

100 TABLET in 1 BOTTLE (0039-0223-10)
Marketing Start Date2009-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0039-0223-10 [00039022310]

AMARYL TABLET
Marketing CategoryNDA
Application NumberNDA020496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-18

Drug Details

Active Ingredients

IngredientStrength
GLIMEPIRIDE4 mg/1

OpenFDA Data

SPL SET ID:222b630b-7e09-43b4-9894-3d87f10add91
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 153591
  • 199245
  • 199247
  • 199246
  • 153843
  • 153845
    • UPC Code
  • 0300390223103
  • 0300390222106
  • 0300390221109

    • Pharmacological Class

    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]
    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]

    NDC Crossover Matching brand name "AMARYL" or generic name "Glimepiride"

    NDCBrand NameGeneric Name
    0039-0221AMARYLglimepiride
    0039-0222AMARYLglimepiride
    0039-0223AMARYLglimepiride
    0093-7254GlimepirideGlimepiride
    0093-7255GlimepirideGlimepiride
    0093-7256GlimepirideGlimepiride
    0378-4011Glimepirideglimepiride
    0378-4012Glimepirideglimepiride
    0378-4013Glimepirideglimepiride
    0440-6564GlimepirideGlimepiride
    0440-6565GlimepirideGlimepiride
    0440-6566GlimepirideGlimepiride
    0615-6575GlimepirideGlimepiride
    0615-6576GlimepirideGlimepiride
    0615-7523GlimepirideGlimepiride
    0615-8332GlimepirideGlimepiride
    0615-8333GlimepirideGlimepiride
    0615-8334GlimepirideGlimepiride
    10544-217GlimepirideGlimepiride
    10544-219GlimepirideGlimepiride
    16571-773GlimepirideGlimepiride
    16571-774GlimepirideGlimepiride
    16571-775GlimepirideGlimepiride
    16729-001GlimepirideGlimepiride
    16729-002GlimepirideGlimepiride
    16729-003GlimepirideGlimepiride
    21695-746GlimepirideGlimepiride
    21695-747GlimepirideGlimepiride
    21695-993GlimepirideGlimepiride
    33261-831GlimepirideGlimepiride
    33261-892GlimepirideGlimepiride
    33261-961GlimepirideGlimepiride
    35356-896GlimepirideGlimepiride
    42571-100GlimepirideGlimepiride

    Trademark Results [AMARYL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AMARYL
    AMARYL
    74296984 1912174 Live/Registered
    SANOFI-AVENTIS DEUTSCHLAND GMBH
    1992-07-21
    AMARYL
    AMARYL
    73573722 not registered Dead/Abandoned
    COOPERS ANIMAL HEALTH LIMITED
    1985-12-16
    AMARYL
    AMARYL
    73086333 1069674 Dead/Cancelled
    Amar Dye-Chem Limited
    1976-05-06
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.