10135-543 : Ursodiol 300 mg Oral Capsule


NDC: 10135-543
Labeler: Marlex Pharmaceuticals Inc
Product Type: Human Prescription Drug
Drug Name:  Ursodiol
Dosage Form: Oral Capsule
Application #: ANDA079082
Rev. Date: 


Appearance:


Markings: Logo;LANNETT;1326
Shapes:  Capsule
Colors:  Pink / White
Size (mm): 22
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 10135-543-01: 100 CAPSULE IN 1 BOTTLE (10135‑543‑01)

Active Ingredients:

  • Ursodiol

Dosage Strength:

  • 300 mg

Inactive Ingredients:

  • Starch, Corn
  • Silicon Dioxide
  • Magnesium Stearate
  • Fd&c Blue No. 1
  • Fd&c Red No. 40
  • Fd&c Yellow No. 6
  • Titanium Dioxide
  • Gelatin
  • Shellac
  • Alcohol
  • Ferrosoferric Oxide
  • Butyl Alcohol
  • Propylene Glycol
  • Fd&c Blue No. 2
  • D&c Yellow No. 10
  • Methyl Alcohol

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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
  • 0904-6483 Ursodiol 300 mg Oral Capsule by Major Pharmaceuticals
  • 0904-6890 Ursodiol 250 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-7168 Ursodiol 300 mg Oral Capsule by Major Pharmaceuticals
  • 10702-237 Ursodiol 300 mg Oral Capsule by Kvk-tech, Inc.
  • 16590-349 Ursodiol 300 mg Oral Capsule by Stat Rx USA LLC
  • More related products ...

NDC QR Code

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NDC 10135-543 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.