NDC 0378-0215

Tolbutamide

Tolbutamide

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

Product ID0378-0215_a0b07fb5-665b-423a-a483-733b2da5b55c
NDC0378-0215
Product TypeHuman Prescription Drug
Proprietary NameTolbutamide
Generic NameTolbutamide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1989-11-01
Marketing End Date2021-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA086445
Labeler NameMylan Pharmaceuticals Inc.
Substance NameTOLBUTAMIDE
Active Ingredient Strength500 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN

Packaging

NDC 0378-0215-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0215-01)
Marketing Start Date1989-11-01
Marketing End Date2021-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0215-01 [00378021501]

Tolbutamide TABLET
Marketing CategoryANDA
Application NumberANDA086445
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1989-11-01
Marketing End Date2021-09-30

NDC 0378-0215-05 [00378021505]

Tolbutamide TABLET
Marketing CategoryANDA
Application NumberANDA086445
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1989-11-01
Marketing End Date2018-12-31

Drug Details

Active Ingredients

IngredientStrength
TOLBUTAMIDE500 mg/1

OpenFDA Data

SPL SET ID:3995eed8-39ec-ce5e-8cc2-062f93445c8d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198294

    • Pharmacological Class

    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]
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