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  4. NDC Product Code: 54868-6435 Zenpep

NDC 54868-6435 Zenpep

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-6435?
  5. Zenpep Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 54868-6435 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
54868-6435
Proprietary Name:
Zenpep
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
c6c845b3-8f22-454e-b0f8-ed2cdd59e8dd
FDA Application Number: [6]
NDA022210
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
09-12-2014
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
EURAND;10
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-6435?

The NDC code 54868-6435 is assigned by the FDA to the product Zenpep which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-6435-0 90 capsule, delayed release in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Zenpep?

This medication contains digestive enzymes to help break down and digest fats, starch, and proteins in food. It is used in conditions where the pancreas cannot make or does not release enough digestive enzymes into the small intestines to digest the food (conditions such as chronic pancreatitis, cystic fibrosis, cancer of the pancreas, post-pancreatectomy, post-gastrointestinal bypass surgery).

Which are Zenpep UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Zenpep Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Zenpep?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 861692 - lipase 10,000 UNT / amylase 55,000 UNT / protease 34,000 UNT Delayed Release Oral Capsule
  • RxCUI: 861692 - amylase 55000 UNT / lipase 10000 UNT / protease 34000 UNT Delayed Release Oral Capsule
  • RxCUI: 861692 - amylase 55,000 UNT / lipase 10,000 UNT / protease 34,000 UNT Delayed Release Oral Capsule
  • RxCUI: 861692 - amylases 55,000 UNT / endopeptidases 34,000 UNT / lipase 10,000 UNT Delayed Release Oral Capsule
  • RxCUI: 861830 - Zenpep 10,000 UNT / 55,000 UNT / 34,000 UNT Delayed Release Oral Capsule

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".