68001-378 : Ursodiol 500 mg Oral Tablet


NDC: 68001-378
Labeler: Bluepoint Laboratories
Product Type: Human Prescription Drug
Drug Name:  Ursodiol
Dosage Form: Oral Tablet
Application #: ANDA090801
Rev. Date: 


Appearance:


Markings: U11;Breakline
Shapes:  Oval
Colors:  White
Size (mm): 16
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.

U11 Breakline: (68462-474) Ursodiol 500 mg Oral Tablet by Bluepoint Laboratories
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:

  • 68001-378-00: 100 TABLET IN 1 BOTTLE (68001‑378‑00)

Active Ingredients:

  • Ursodiol

Dosage Strength:

  • 500 mg

Inactive Ingredients:

  • Microcrystalline Cellulose
  • Povidone, Unspecified
  • Sodium Starch Glycolate Type a Potato
  • Magnesium Stearate
  • Ethylcellulose, Unspecified
  • Dibutyl Sebacate
  • Carnauba Wax
  • Hypromellose, Unspecified
  • Polyethylene Glycol 3350
  • Polyethylene Glycol 8000
  • Cetyl Alcohol
  • Sodium Lauryl Sulfate /

Pharmaceutical Classes:

  • Bile Acid [EPC]
  • Bile Acids and Salts [CS]

Related Products:

Based on records with the same trade name.
  • 68001-226 Ursodiol 250 mg/1 Oral Tablet, Film Coated by Bluepoint Laboratories
  • 68001-227 Ursodiol 500 mg/1 Oral Tablet, Film Coated by Bluepoint Laboratories
  • 68001-343 Ursodiol 250 mg Oral Tablet, Film Coated by Bluepoint Laboratories
  • 68001-344 Ursodiol 500 mg Oral Tablet, Film Coated by Bluepoint Laboratories
  • 68001-377 Ursodiol 250 mg Oral Tablet by Bluepoint Laboratories
  • 0093-5360 Ursodiol 250 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5361 Ursodiol 500 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0115-1524 Ursodiol 250 mg Oral Tablet, Film Coated by Global Pharmaceuticals, Division of Impax Laboratories, Inc.
  • 0115-1525 Ursodiol 500 mg Oral Tablet, Film Coated by Global Pharmaceuticals, Division of Impax Laboratories, Inc.
  • 0115-9933 Ursodiol 250 mg Oral Tablet, Film Coated by Impax Generics
  • 0115-9934 Ursodiol 500 mg Oral Tablet, Film Coated by Impax Generics
  • 0378-1730 Ursodiol 300 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0527-1326 Ursodiol 300 mg Oral Capsule by Lannett Company, Inc.
  • 0591-2368 Ursodiol 250 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-2369 Ursodiol 500 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-2998 Ursodiol 250 mg Oral Tablet by Actavis Pharma, Inc.
  • 0591-3005 Ursodiol 500 mg Oral Tablet by Actavis Pharma, Inc.
  • 0591-3159 Ursodiol 300 mg Oral Capsule by Watson Laboratories, Inc.
  • 0615-1374 Ursodiol 300 mg Oral Capsule by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0904-6221 Ursodiol 300 mg Oral Capsule by Major Pharmaceuticals
  • More related products ...

NDC QR Code

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NDC 68001-378 QR Code

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Note: The RxChat 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.