58914-785 : Urso 250 mg Oral Tablet


NDC: 58914-785
Labeler: Aptalis Pharma Us, Inc.
Product Type: Human Prescription Drug
Drug Name:  Urso 250
Dosage Form: Oral Tablet, Film Coated
Application #: NDA020675
Rev. Date: 


Appearance:


Markings: URS785
Shapes:  Oval
Colors:  White
Size (mm): 10
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.

URS785: (58914-785) Urso 250 mg Oral Tablet by Aptalis Pharma Us, 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:

  • 58914-785-10: 100 TABLET, FILM COATED IN 1 BOTTLE (58914‑785‑10)

Active Ingredients:

  • Ursodiol

Dosage Strength:

  • 250 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Povidone K29/32
  • Polyethylene Glycol 3350
  • Magnesium Stearate
  • Hypromelloses
  • Ethylcelluloses
  • Dibutyl Sebacate
  • Polyethylene Glycol 8000
  • Carnauba Wax
  • Sodium Starch Glycolate Type a Potato

Pharmaceutical Classes:

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

NDC QR Code

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NDC 58914-785 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.