62541-404 : Pancreaze Oral Capsule, Delayed Release


NDC62541-404
Labeler: Vivus, Inc.
Product Type: Human Prescription Drug
Drug Name:  Pancreaze
Dosage Form: Oral Capsule, Delayed Release
Application #: NDA022523
Rev. Date: 


Appearance:


Markings: VIVUS;MT;16
Shapes:  Capsule
Colors:  Orange
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:

  • 62541-404-10: 1 BOTTLE, GLASS IN 1 CARTON (62541‑404‑10) > 100 CAPSULE, DELAYED RELEASE IN 1 BOTTLE, GLASS

Active Ingredients:

  • Pancrelipase Lipase
  • Pancrelipase Amylase
  • Pancrelipase Protease

Dosage Strength:

  • 16800 [USP'U]/1
  • 98400 [USP'U]/1
  • 56800 [USP'U]/1

Inactive Ingredients:

  • Microcrystalline Cellulose
  • Crospovidone (15 Mpa.s At 5%)
  • Silicon Dioxide
  • Magnesium Stearate
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Triethyl Citrate
  • Talc
  • Dimethicone
  • Gelatin, Unspecified
  • Titanium Dioxide
  • Sodium Lauryl Sulfate
  • Sorbitan Monolaurate
  • Ferric Oxide Yellow /

Related Products:

Based on records with the same trade name.
  • 62541-401 Pancreaze Oral Capsule, Delayed Release by Vivus, Inc.
  • 62541-402 Pancreaze Oral Capsule, Delayed Release by Vivus, Inc.
  • 62541-403 Pancreaze Oral Capsule, Delayed Release by Vivus, Inc.
  • 62541-405 Pancreaze Oral Capsule, Delayed Release by Vivus, Inc.
  • 62541-406 Pancreaze Oral Capsule, Delayed Release by Vivus, Inc.
  • 50458-341 Pancreaze (Pancrelipase Lipase 4200 [usp'u] / Pancrelipase Amylase 17500 [usp'u] / Pancrelipase Protease 10000 [usp'u]) by Janssen Pharmaceuticals, Inc.
  • 50458-342 Pancreaze (Pancrelipase Lipase 10500 [usp'u] / Pancrelipase Amylase 43750 [usp'u] / Pancrelipase Protease 25000 [usp'u]) by Janssen Pharmaceuticals, Inc.
  • 50458-343 Pancreaze (Pancrelipase Lipase 16800 [usp'u] / Pancrelipase Amylase 70000 [usp'u] / Pancrelipase Protease 40000 [usp'u]) by Janssen Pharmaceuticals, Inc.
  • 50458-346 Pancreaze (Pancrelipase Lipase 21000 [usp'u] / Pancrelipase Amylase 61000 [usp'u] / Pancrelipase Protease 37000 [usp'u]) by Janssen Pharmaceuticals, Inc.
  • 50458-347 Pancreaze Oral Capsule, Delayed Release by Janssen Pharmaceuticals, Inc.

NDC 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.