zenpep

Generic: pancrelipase lipase, pancrelipase protease, pancrelipase amylase

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

Drug Facts

Product Profile

Brand Name zenpep
Generic Name pancrelipase lipase, pancrelipase protease, pancrelipase amylase
Labeler aimmune therapeutics, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

pancrelipase amylase 105000 [USP'U]/1, pancrelipase lipase 25000 [USP'U]/1, pancrelipase protease 79000 [USP'U]/1

Manufacturer
Aimmune Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 73562-116
Product ID 73562-116_6b24ef38-2c65-4b1d-804a-a8301db084e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA022210
Listing Expiration 2026-12-31
Marketing Start 2020-11-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73562116
Hyphenated Format 73562-116

Supplemental Identifiers

RxCUI
1594671 1594673 1595290 1595292 1595455 1595457 1595460 1595462 1595471 1595473 1595476 1595478 1995477 1995479 2669470 2669472
UPC
0373562115018 0373562110013
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 zenpep (source: ndc)
Generic Name pancrelipase lipase, pancrelipase protease, pancrelipase amylase (source: ndc)
Application Number BLA022210 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 105000 [USP'U]/1
  • 25000 [USP'U]/1
  • 79000 [USP'U]/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-116-01)
  • 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-116-12)
source: ndc

Packages (2)

73562-116-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-116-01) 73562-116-12 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-116-12)

Ingredients (3)

pancrelipase amylase (105000 [USP'U]/1) pancrelipase lipase (25000 [USP'U]/1) pancrelipase protease (79000 [USP'U]/1)

Linked Drug Pages (1)

Zenpep ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6b24ef38-2c65-4b1d-804a-a8301db084e6", "openfda": {"upc": ["0373562115018", "0373562110013"], "unii": ["8MYC33932O", "3560D81V50", "YOJ58O116E"], "rxcui": ["1594671", "1594673", "1595290", "1595292", "1595455", "1595457", "1595460", "1595462", "1595471", "1595473", "1595476", "1595478", "1995477", "1995479", "2669470", "2669472"], "spl_set_id": ["7f16f2d4-8df6-4bd7-ac10-56994fa257b0"], "manufacturer_name": ["Aimmune Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-116-01)", "package_ndc": "73562-116-01", "marketing_start_date": "20201101"}, {"sample": true, "description": "12 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-116-12)", "package_ndc": "73562-116-12", "marketing_start_date": "20210501"}], "brand_name": "Zenpep", "product_id": "73562-116_6b24ef38-2c65-4b1d-804a-a8301db084e6", "dosage_form": "CAPSULE, DELAYED RELEASE", "product_ndc": "73562-116", "generic_name": "pancrelipase lipase, pancrelipase protease, pancrelipase amylase", "labeler_name": "Aimmune Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zenpep", "active_ingredients": [{"name": "PANCRELIPASE AMYLASE", "strength": "105000 [USP'U]/1"}, {"name": "PANCRELIPASE LIPASE", "strength": "25000 [USP'U]/1"}, {"name": "PANCRELIPASE PROTEASE", "strength": "79000 [USP'U]/1"}], "application_number": "BLA022210", "marketing_category": "BLA", "marketing_start_date": "20201101", "listing_expiration_date": "20261231"}