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NDC 59767-0008-99 PERTZYE 30250; 8000; 28750 [USP'U]/1; [USP'U]/1; [USP'U]/1 Details
PERTZYE 30250; 8000; 28750 [USP'U]/1; [USP'U]/1; [USP'U]/1
PERTZYE is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Digestive Care, Inc.. The primary component is PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE.
MedlinePlus Drug Summary
Pancrelipase delayed-release capsules (Creon, Pancreaze, Pertzye, Ultresa, Zenpep) are used to improve digestion of food in children and adults who do not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have a condition that affects the pancreas (a gland that produces several important substances including enzymes needed to digest food) such as cystic fibrosis (an inborn disease that causes the body to produce thick, sticky mucus that may clog the pancreas, the lungs, and other parts of the body), chronic pancreatitis (swelling of the pancreas that does not go away), or a blockage in the passages between the pancreas and the intestine. Pancrelipase delayed-release capsules (Creon, Pancreaze, Zenpep) are also used to improve digestion of food in infants who do not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have cystic fibrosis or another condition that affects the pancreas. Pancrelipase delayed-release capsules (Creon) are also used to improve digestion in people who have had surgery to remove all or part of the pancreas or stomach. Pancrelipase tablets (Viokace) are used along with another medication (proton pump inhibitor; PPI) to improve digestion of foods in adults who have chronic pancreatitis or who have had surgery to remove the pancreas. Pancrelipase is in a class of medications called enzymes. Pancrelipase acts in place of the enzymes normally made by the pancreas. It works to decrease fatty bowel movements and to improve nutrition by breaking down fats, proteins, and starches from food into smaller substances that can be absorbed from the intestine.
Related Packages: 59767-0008-99Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Pancrelipase
Product Information
NDC | 59767-0008 |
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Product ID | 59767-008_6b6ec566-325a-4038-8f90-8c02e617ad06 |
Associated GPIs | 51200024006725 |
GCN Sequence Number | 069299 |
GCN Sequence Number Description | lipase/protease/amylase CAPSULE DR 8K-28.75K ORAL |
HIC3 | D8A |
HIC3 Description | PANCREATIC ENZYMES |
GCN | 32298 |
HICL Sequence Number | 008060 |
HICL Sequence Number Description | LIPASE/PROTEASE/AMYLASE |
Brand/Generic | Brand |
Proprietary Name | PERTZYE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | pancrelipase |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | CAPSULE, DELAYED RELEASE |
Route | ORAL |
Active Ingredient Strength | 30250; 8000; 28750 |
Active Ingredient Units | [USP'U]/1; [USP'U]/1; [USP'U]/1 |
Substance Name | PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE |
Labeler Name | Digestive Care, Inc. |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA022175 |
Listing Certified Through | 2024-12-31 |
Package
NDC 59767-0008-99 (59767000899)
NDC Package Code | 59767-008-99 |
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Billing NDC | 59767000899 |
Package | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-008-99) |
Marketing Start Date | 2012-05-17 |
NDC Exclude Flag | N |
Pricing Information | N/A |