58914-003 : Ultresa (Amylases 27,600 Unt / Lipase 13,800 Unt / Proteases 27,600 Unt) Delayed Release Capsule


NDC58914-003
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: 13800UL;AXCA
Shapes:  Capsule
Colors:  Yellow
Size (mm): 19
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:

  • 58914-003-10: 1 BOTTLE IN 1 CARTON (58914‑003‑10) > 100 CAPSULE, DELAYED RELEASE IN 1 BOTTLE

Active Ingredients:

  • Pancrelipase Amylase
  • Pancrelipase Lipase
  • Pancrelipase Protease

Dosage Strength:

  • 27600 [USP'U]/1
  • 13800 [USP'U]/1
  • 27600 [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
  • Ferric Oxide Yellow
  • Titanium Dioxide

Related Products:

Based on records with the same trade name.
  • 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
  • 58914-019 Ultresa (Amylases 41,400 Unt / Lipase 20,700 Unt / Proteases 41,400 Unt) Delayed Release Capsule by Aptalis Pharma Us, Inc

NDC QR Code

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NDC 58914-003 QR Code

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