42865-101 : Zenpep 10 (Amylases 55,000 Unt / Lipase 10,000 Unt / Proteases 34,000 Unt) Delayed Release Capsule


NDC: 42865-101
Labeler: Aptalis Pharma Us, Inc.
Product Type: Human Prescription Drug
Drug Name:  Zenpep
Dosage Form: Oral Capsule, Delayed Release
Application #: NDA022210
Rev. Date: 


Appearance:


Markings: EURAND;10
Shapes:  Capsule
Colors:  Yellow / White
Size (mm): 18
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.

EURAND 10: (42865-101) Zenpep 10 (Amylases 55,000 Unt / Lipase 10,000 Unt / Proteases 34,000 Unt) Delayed Release Capsule 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:

  • 42865-101-01: 12 CAPSULE, DELAYED RELEASE IN 1 BOTTLE, GLASS (42865‑101‑01)
  • 42865-101-02: 100 CAPSULE, DELAYED RELEASE IN 1 BOTTLE, GLASS (42865‑101‑02)

Active Ingredients:

  • Pancrelipase Amylase
  • Pancrelipase Lipase
  • Pancrelipase Protease

Dosage Strength:

  • 55000 [USP'U]/1
  • 10000 [USP'U]/1
  • 34000 [USP'U]/1

Inactive Ingredients:

  • Croscarmellose Sodium
  • Hydrogenated Castor Oil
  • Silicon Dioxide
  • Cellulose, Microcrystalline
  • Magnesium Stearate
  • Talc
  • Triethyl Citrate
  • Hypromellose Phthalate (31% Phthalate, 170 Cst)
  • Carrageenan
  • Potassium Chloride
  • Titanium Dioxide
  • Hypromelloses
  • Water
  • Ferric Oxide Yellow

Related Products:

Based on records with the same trade name.
  • 42865-100 Zenpep 5 Delayed Release Capsule by Aptalis Pharma Us, Inc.
  • 42865-102 Zenpep 15 Delayed Release Capsule by Aptalis Pharma Us, Inc.
  • 42865-103 Zenpep 20 Delayed Release Capsule by Aptalis Pharma Us, Inc.
  • 42865-104 Zenpep 3 (Amylases 16,000 Unt / Lipase 3000 Unt / Protease 10,000 Unt) Delayed Release Capsule by Aptalis Pharma Us, Inc.
  • 42865-105 Zenpep 25 (Amylases 136,000 Unt / Lipase 25,000 Unt / Protease 85,000 Unt) Delayed Release Capsule by Aptalis Pharma Us, Inc.
  • 42865-300 Zenpep Oral Capsule, Delayed Release by Aptalis Pharma Us, Inc.
  • 42865-302 Zenpep Oral Capsule, Delayed Release by Aptalis Pharma Us, Inc.
  • 42865-303 Zenpep Oral Capsule, Delayed Release by Aptalis Pharma Us, Inc.
  • 42865-304 Zenpep Oral Capsule, Delayed Release by Aptalis Pharma Us, Inc.
  • 42865-305 Zenpep Oral Capsule, Delayed Release by Aptalis Pharma Us, Inc.
  • 42865-306 Zenpep Oral Capsule, Delayed Release by Aptalis Pharma Us, Inc.
  • 42865-307 Zenpep Oral Capsule, Delayed Release by Aptalis Pharma Us, Inc.
  • 0023-6110 Zenpep Oral Capsule, Delayed Release by Allergan, Inc.
  • 0023-6111 Zenpep Oral Capsule, Delayed Release by Allergan, Inc.
  • 0023-6112 Zenpep Oral Capsule, Delayed Release by Allergan, Inc.
  • 0023-6113 Zenpep Oral Capsule, Delayed Release by Allergan, Inc.
  • 0023-6114 Zenpep Oral Capsule, Delayed Release by Allergan, Inc.
  • 0023-6115 Zenpep Oral Capsule, Delayed Release by Allergan, Inc.
  • 0023-6116 Zenpep Oral Capsule, Delayed Release by Allergan, Inc.
  • 54868-6435 Zenpep Oral Capsule, Delayed Release by Physicians Total Care, Inc.
  • More related products ...

NDC QR Code

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NDC 42865-101 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.