NDC 0378-4011

Glimepiride

Glimepiride

Glimepiride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc. The primary component is Glimepiride.

Product ID0378-4011_4077b3a3-3d8e-4aa4-a681-9a795298e265
NDC0378-4011
Product TypeHuman Prescription Drug
Proprietary NameGlimepiride
Generic NameGlimepiride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2006-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA077624
Labeler NameMylan Pharmaceuticals Inc
Substance NameGLIMEPIRIDE
Active Ingredient Strength1 mg/1
Pharm ClassesSulfonylurea [E
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-4011-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-4011-01)
Marketing Start Date2006-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4011-05 [00378401105]

Glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA077624
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-03-01
Marketing End Date2014-11-25

NDC 0378-4011-01 [00378401101]

Glimepiride TABLET
Marketing CategoryANDA
Application NumberANDA077624
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-03-01
Marketing End Date2020-05-31

Drug Details

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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