viokace

Generic: pancrelipase

Labeler: aimmune therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name viokace
Generic Name pancrelipase
Labeler aimmune therapeutics, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pancrelipase amylase 39150 [USP'U]/1, pancrelipase lipase 10440 [USP'U]/1, pancrelipase protease 39150 [USP'U]/1

Manufacturer
Aimmune Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 73562-104
Product ID 73562-104_95ece3e2-a51f-4f4c-81ec-71aa2930a158
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA022542
Listing Expiration 2026-12-31
Marketing Start 2021-03-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73562104
Hyphenated Format 73562-104

Supplemental Identifiers

RxCUI
1247379 1247381 1247386 1247388
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 viokace (source: ndc)
Generic Name pancrelipase (source: ndc)
Application Number BLA022542 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 39150 [USP'U]/1
  • 10440 [USP'U]/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (73562-104-10) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (1)

73562-104-10 1 BOTTLE in 1 CARTON (73562-104-10) / 100 TABLET in 1 BOTTLE

Ingredients (3)

pancrelipase amylase (39150 [USP'U]/1) pancrelipase lipase (10440 [USP'U]/1) pancrelipase protease (39150 [USP'U]/1)

Linked Drug Pages (1)

Viokace ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "95ece3e2-a51f-4f4c-81ec-71aa2930a158", "openfda": {"unii": ["8MYC33932O", "3560D81V50", "YOJ58O116E"], "rxcui": ["1247379", "1247381", "1247386", "1247388"], "spl_set_id": ["58bdb8de-582d-44e6-9b72-8d5a42fdf501"], "manufacturer_name": ["Aimmune Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (73562-104-10)  / 100 TABLET in 1 BOTTLE", "package_ndc": "73562-104-10", "marketing_start_date": "20210301"}], "brand_name": "Viokace", "product_id": "73562-104_95ece3e2-a51f-4f4c-81ec-71aa2930a158", "dosage_form": "TABLET", "product_ndc": "73562-104", "generic_name": "Pancrelipase", "labeler_name": "Aimmune Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Viokace", "active_ingredients": [{"name": "PANCRELIPASE AMYLASE", "strength": "39150 [USP'U]/1"}, {"name": "PANCRELIPASE LIPASE", "strength": "10440 [USP'U]/1"}, {"name": "PANCRELIPASE PROTEASE", "strength": "39150 [USP'U]/1"}], "application_number": "BLA022542", "marketing_category": "BLA", "marketing_start_date": "20210301", "listing_expiration_date": "20261231"}