pertzye

Generic: pancrelipase

Labeler: digestive care, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name pertzye
Generic Name pancrelipase
Labeler digestive care, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

pancrelipase amylase 60500 [USP'U]/1, pancrelipase lipase 16000 [USP'U]/1, pancrelipase protease 57500 [USP'U]/1

Manufacturer
Digestive Care, Inc.

Identifiers & Regulatory

Product NDC 59767-016
Product ID 59767-016_2ae80639-0555-49c6-bae7-00f43983e614
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA022175
Listing Expiration 2026-12-31
Marketing Start 2012-05-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59767016
Hyphenated Format 59767-016

Supplemental Identifiers

RxCUI
1294122 1294128 1294481 1294483 1543004 1543006 1929116 1929118
UNII
8MYC33932O 3560D81V50 YOJ58O116E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pertzye (source: ndc)
Generic Name pancrelipase (source: ndc)
Application Number BLA022175 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60500 [USP'U]/1
  • 16000 [USP'U]/1
  • 57500 [USP'U]/1
source: ndc
Packaging
  • 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-00)
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-01)
  • 250 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-02)
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-99)
source: ndc

Packages (4)

59767-016-00 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-00) 59767-016-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-01) 59767-016-02 250 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-02) 59767-016-99 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-99)

Ingredients (3)

pancrelipase amylase (60500 [USP'U]/1) pancrelipase lipase (16000 [USP'U]/1) pancrelipase protease (57500 [USP'U]/1)

Linked Drug Pages (1)

PERTZYE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2ae80639-0555-49c6-bae7-00f43983e614", "openfda": {"unii": ["8MYC33932O", "3560D81V50", "YOJ58O116E"], "rxcui": ["1294122", "1294128", "1294481", "1294483", "1543004", "1543006", "1929116", "1929118"], "spl_set_id": ["481eec00-9abf-11dd-b71c-0002a5d5c51b"], "manufacturer_name": ["Digestive Care, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-00)", "package_ndc": "59767-016-00", "marketing_start_date": "20140123"}, {"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-01)", "package_ndc": "59767-016-01", "marketing_start_date": "20120517"}, {"sample": false, "description": "250 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-02)", "package_ndc": "59767-016-02", "marketing_start_date": "20120517"}, {"sample": true, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59767-016-99)", "package_ndc": "59767-016-99", "marketing_start_date": "20120517"}], "brand_name": "PERTZYE", "product_id": "59767-016_2ae80639-0555-49c6-bae7-00f43983e614", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "59767-016", "generic_name": "pancrelipase", "labeler_name": "Digestive Care, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PERTZYE", "active_ingredients": [{"name": "PANCRELIPASE AMYLASE", "strength": "60500 [USP'U]/1"}, {"name": "PANCRELIPASE LIPASE", "strength": "16000 [USP'U]/1"}, {"name": "PANCRELIPASE PROTEASE", "strength": "57500 [USP'U]/1"}], "application_number": "BLA022175", "marketing_category": "BLA", "marketing_start_date": "20120517", "listing_expiration_date": "20261231"}