NDC 42571-105

Glimepiride

Glimepiride

Glimepiride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Micro Labs Limited. The primary component is Glimepiride.

Product ID42571-105_7867d561-3c92-5693-e053-2a91aa0a624c
NDC42571-105
Product TypeHuman Prescription Drug
Proprietary NameGlimepiride
Generic NameGlimepiride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-06-13
Marketing CategoryANDA / ANDA
Application NumberANDA091220
Labeler NameMicro Labs Limited
Substance NameGLIMEPIRIDE
Active Ingredient Strength8 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42571-105-01

100 TABLET in 1 BOTTLE (42571-105-01)
Marketing Start Date2013-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42571-105-05 [42571010505]

Glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA091220
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-06-13

NDC 42571-105-01 [42571010501]

Glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA091220
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-06-13

NDC 42571-105-10 [42571010510]

Glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA091220
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-16
Marketing End Date2017-01-02

Drug Details

Active Ingredients

IngredientStrength
GLIMEPIRIDE8 mg/1

OpenFDA Data

SPL SET ID:60e9397e-83b9-489e-9683-6f87e458bbaa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1361495
  • 1361493
  • 199245
  • 199247
  • 199246
  • 153842
    • UPC Code
  • 0342571102012
  • 0342571103019
  • 0342571104016
  • 0342571101015
  • 0342571100018

    • Pharmacological Class

    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]

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

    NDCBrand NameGeneric Name
    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
    68001-179GlimepirideGlimepiride
    68001-177GlimepirideGlimepiride
    68001-178GlimepirideGlimepiride
    68071-1942GlimepirideGlimepiride
    68071-1910GlimepirideGlimepiride
    68071-3024GlimepirideGlimepiride
    68071-1991GlimepirideGlimepiride
    68071-3068GlimepirideGlimepiride
    68071-3239GlimepirideGlimepiride
    68084-327GlimepirideGlimepiride
    68084-326GlimepirideGlimepiride
    68084-788GlimepirideGlimepiride
    68645-572GlimepirideGlimepiride
    68645-573GlimepirideGlimepiride
    68788-6801GlimepirideGlimepiride
    68788-6818GlimepirideGlimepiride
    68788-6436GlimepirideGlimepiride
    68788-6411GlimepirideGlimepiride
    69452-129GlimepirideGlimepiride
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