pancreaze

Generic: pancrelipase lipase, pancrelipase amylase, and pancrelipase protease

Labeler: vivus llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name pancreaze
Generic Name pancrelipase lipase, pancrelipase amylase, and pancrelipase protease
Labeler vivus llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

pancrelipase amylase 15200 [USP'U]/1, pancrelipase lipase 2600 [USP'U]/1, pancrelipase protease 8800 [USP'U]/1

Manufacturer
VIVUS LLC

Identifiers & Regulatory

Product NDC 62541-401
Product ID 62541-401_36e934b1-3fbb-8f0c-e063-6294a90a968c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA022523
Listing Expiration 2026-12-31
Marketing Start 2016-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62541401
Hyphenated Format 62541-401

Supplemental Identifiers

RxCUI
1806919 1806921 1806924 1806926 1806929 1806931 1806964 1806966 2478453 2478455 2564410 2564412
UPC
0362541402102 0362541403109 0362541405103 0362541401105 0362541406100 0362541404106
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 pancreaze (source: ndc)
Generic Name pancrelipase lipase, pancrelipase amylase, and pancrelipase protease (source: ndc)
Application Number BLA022523 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15200 [USP'U]/1
  • 2600 [USP'U]/1
  • 8800 [USP'U]/1
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (62541-401-10) / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS
source: ndc

Packages (1)

62541-401-10 1 BOTTLE, GLASS in 1 CARTON (62541-401-10) / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS

Ingredients (3)

pancrelipase amylase (15200 [USP'U]/1) pancrelipase lipase (2600 [USP'U]/1) pancrelipase protease (8800 [USP'U]/1)

Linked Drug Pages (1)

PANCREAZE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "36e934b1-3fbb-8f0c-e063-6294a90a968c", "openfda": {"upc": ["0362541402102", "0362541403109", "0362541405103", "0362541401105", "0362541406100", "0362541404106"], "unii": ["8MYC33932O", "3560D81V50", "YOJ58O116E"], "rxcui": ["1806919", "1806921", "1806924", "1806926", "1806929", "1806931", "1806964", "1806966", "2478453", "2478455", "2564410", "2564412"], "spl_set_id": ["e8f5d2fe-728d-42af-99a6-83dddc6539c5"], "manufacturer_name": ["VIVUS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (62541-401-10)  / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS", "package_ndc": "62541-401-10", "marketing_start_date": "20160801"}], "brand_name": "PANCREAZE", "product_id": "62541-401_36e934b1-3fbb-8f0c-e063-6294a90a968c", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "62541-401", "generic_name": "PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE", "labeler_name": "VIVUS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PANCREAZE", "active_ingredients": [{"name": "PANCRELIPASE AMYLASE", "strength": "15200 [USP'U]/1"}, {"name": "PANCRELIPASE LIPASE", "strength": "2600 [USP'U]/1"}, {"name": "PANCRELIPASE PROTEASE", "strength": "8800 [USP'U]/1"}], "application_number": "BLA022523", "marketing_category": "BLA", "marketing_start_date": "20160801", "listing_expiration_date": "20261231"}