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 ID: 0378-0215_a0b07fb5-665b-423a-a483-733b2da5b55c
• NDC: 0378-0215
• Product Type: Human Prescription Drug
• Proprietary Name: Tolbutamide
• Generic Name: Tolbutamide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1989-11-01
• Marketing End Date: 2021-09-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA086445
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: TOLBUTAMIDE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
• NDC Exclude Flag: N

Packaging

NDC 0378-0215-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0215-01)

• Marketing Start Date: 1989-11-01
• Marketing End Date: 2021-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0215-01 [00378021501]

Tolbutamide TABLET

• Marketing Category: ANDA
• Application Number: ANDA086445
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1989-11-01
• Marketing End Date: 2021-09-30

NDC 0378-0215-05 [00378021505]

Tolbutamide TABLET

• Marketing Category: ANDA
• Application Number: ANDA086445
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1989-11-01
• Marketing End Date: 2018-12-31

Drug Details

Active Ingredients

Ingredient	Strength
TOLBUTAMIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 3995eed8-39ec-ce5e-8cc2-062f93445c8d
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 982XCM1FOI
• RxNorm Concept Unique ID - RxCUI:
  • 198294

Pharmacological Class

• Sulfonylurea [EPC]
• Sulfonylurea Compounds [CS]