NDC 61919-250

GLIMEPIRIDE

Glimepiride

GLIMEPIRIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Glimepiride.

Product ID61919-250_2b57dfa7-f2c3-45ca-e054-00144ff8d46c
NDC61919-250
Product TypeHuman Prescription Drug
Proprietary NameGLIMEPIRIDE
Generic NameGlimepiride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-02-04
Marketing CategoryANDA / ANDA
Application NumberANDA078181
Labeler NameDIRECT RX
Substance NameGLIMEPIRIDE
Active Ingredient Strength4 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-250-04

4 TABLET in 1 BOTTLE (61919-250-04)
Marketing Start Date2016-02-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-250-30 [61919025030]

GLIMEPIRIDE TABLET
Marketing CategoryANDA
Application NumberANDA078181
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-04

NDC 61919-250-82 [61919025082]

GLIMEPIRIDE TABLET
Marketing CategoryANDA
Application NumberANDA078181
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-04

NDC 61919-250-90 [61919025090]

GLIMEPIRIDE TABLET
Marketing CategoryANDA
Application NumberANDA078181
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-04

NDC 61919-250-04 [61919025004]

GLIMEPIRIDE TABLET
Marketing CategoryANDA
Application NumberANDA078181
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-04

NDC 61919-250-60 [61919025060]

GLIMEPIRIDE TABLET
Marketing CategoryANDA
Application NumberANDA078181
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-04

Drug Details

Active Ingredients

IngredientStrength
GLIMEPIRIDE4 mg/1

OpenFDA Data

SPL SET ID:2b57dfa7-f2c2-45ca-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199247

    • 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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