Home NDC 50458-341 PANCREAZE
Product NDC 50458-341
11-digit product format 504580341
Labeler code 50458
Product ID 50458-341_84df27aa-7ea7-11e8-b709-c19a9d46d017
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PANCRELIPASE
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Janssen Pharmaceuticals, Inc.
Application NDA022523
Marketing category NDA
Marketing start 2010-04-12
Marketing end 2019-08-31
Substance PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE
Active strength 4200 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50458-341-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50458-341-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50458-341-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50458-341-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50458-341-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50458-341-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50458-341-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50458-341-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50458-341-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50458-341-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50458-341-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50458-341-60 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PANCRELIPASE AMYLASE ACTIVE INGREDIENT YOJ58O116E PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 PANCRELIPASE LIPASE ACTIVE INGREDIENT 8MYC33932O PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 PANCRELIPASE PROTEASE ACTIVE INGREDIENT 3560D81V50 PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 PANCRELIPASE AMYLASE ACTIVE MOIETY YOJ58O116E PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 PANCRELIPASE LIPASE ACTIVE MOIETY 8MYC33932O PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 PANCRELIPASE PROTEASE ACTIVE MOIETY 3560D81V50 PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 GELATIN INACTIVE INGREDIENT 2G86QN327L PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 SORBITAN MONOLAURATE INACTIVE INGREDIENT 6W9PS8B71J PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM PANCREAZE (PANCRELIPASE) CAPSULE, DELAYED RELEASE [JANSSEN PHARMACEUTICALS, INC.] 5