NDC 57237-151

Glimepiride

Glimepiride

Glimepiride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Citron Pharma Llc. The primary component is Glimepiride.

Product ID57237-151_15f4e6d9-4937-45fe-826a-94753b7be19a
NDC57237-151
Product TypeHuman Prescription Drug
Proprietary NameGlimepiride
Generic NameGlimepiride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-06-29
Marketing CategoryANDA / ANDA
Application NumberANDA202759
Labeler NameCitron Pharma LLC
Substance NameGLIMEPIRIDE
Active Ingredient Strength1 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57237-151-01

100 TABLET in 1 BOTTLE (57237-151-01)
Marketing Start Date2012-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57237-151-01 [57237015101]

Glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA202759
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-06-29
Marketing End Date2019-04-18

NDC 57237-151-05 [57237015105]

Glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA202759
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-06-29
Marketing End Date2019-04-18

Drug Details

Active Ingredients

IngredientStrength
GLIMEPIRIDE1 mg/1

OpenFDA Data

SPL SET ID:ee5d70b7-2a3e-44bb-ace3-380e8c830c7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199245
  • 199247
  • 199246
    • UPC Code
  • 0357237153017
  • 0357237152010
  • 0357237151013

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