0378-0215 : Tolbutamide 500 mg Oral Tablet

Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Tolbutamide
Dosage Form: Oral Tablet
Application #: ANDA086445
Rev. Date: 


Markings: M;13
Shapes:  Round
Colors:  White
Size (mm): 12
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

M 13: (0378-0215) Tolbutamide 500 mg Oral Tablet by Mylan Pharmaceuticals Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0378-0215-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0378‑0215‑01)
  • 0378-0215-05: 500 TABLET IN 1 BOTTLE, PLASTIC (0378‑0215‑05)

Active Ingredients:

  • Tolbutamide

Dosage Strength:

  • 500 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Sodium Lauryl Sulfate
  • Sodium Starch Glycolate Type a Potato

Pharmaceutical Classes:

  • Sulfonylurea [EPC]
  • Sulfonylurea Compounds [Chemical/Ingredient]


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Note: The MedsChat® NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.