58914-019 : Ultresa (Amylases 41,400 Unt / Lipase 20,700 Unt / Proteases 41,400 Unt) Delayed Release Capsule


NDC: 58914-019
Labeler: Aptalis Pharma Us, Inc
Product Type: Human Prescription Drug
Drug Name:  Ultresa
Dosage Form: Oral Capsule, Delayed Release
Application #: NDA022222
Rev. Date: 


Appearance:


Markings: 20700UL;AXCA
Shapes:  Capsule
Colors:  White
Size (mm): 21
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:

  • 58914-019-10: 1 BOTTLE IN 1 CARTON (58914‑019‑10) > 100 CAPSULE, DELAYED RELEASE IN 1 BOTTLE

Active Ingredients:

  • Pancrelipase Amylase
  • Pancrelipase Lipase
  • Pancrelipase Protease

Dosage Strength:

  • 41400 [USP'U]/1
  • 20700 [USP'U]/1
  • 41400 [USP'U]/1

Inactive Ingredients:

  • Colloidal Silicon Dioxide
  • Croscarmellose Sodium
  • Hydrogenated Castor Oil
  • Hypromellose Phthalate (24% Phthalate, 55 Cst)
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Talc
  • Triethyl Citrate
  • Gelatin
  • Titanium Dioxide
  • Ferrosoferric Oxide

Related Products:

Based on records with the same trade name.
  • 58914-003 Ultresa (Amylases 27,600 Unt / Lipase 13,800 Unt / Proteases 27,600 Unt) Delayed Release Capsule by Aptalis Pharma Us, Inc
  • 58914-005 Ultresa (Amylases 46,000 Unt / Lipase 23,000 Unt / Proteases 46,000 Unt) Delayed Release Capsule by Aptalis Pharma Us, Inc
  • 58914-006 Ultresa Oral Capsule, Delayed Release by Aptalis Pharma Us, Inc

NDC QR Code

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NDC 58914-019 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.