Home NDC 17856-1212 Creon
Product NDC 17856-1212
11-digit product format 178561212
Labeler code 17856
Product ID 17856-1212_a5708817-22eb-45e9-a444-2b28f709201b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pancrelipase
Dosage form CAPSULE, DELAYED RELEASE PELLETS
Route ORAL
Labeler Atlantic Biologicals Corps
Application NDA020725
Marketing category NDA
Marketing start 2010-08-13
Marketing end 0000-00-00
Substance PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE
Active strength 12000 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag E
Listing certified through 2018-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17856-1212-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17856-1212-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 17856-1212-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 17856-1212-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17856-1212-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17856-1212-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17856-1212-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17856-1212-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17856-1212-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 17856-1212-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 17856-1212-1 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17856-1212-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 17856-1212-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-1212-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-1212-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-1212-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-1212-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-1212-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 17856-1212-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-1212-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 17856-1212-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 17856-1212-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-1212-1 Creon 1 in 1 POUCH CAPSULE, DELAYED RELEASE PELLETS 1 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PANCRELIPASE AMYLASE ACTIVE INGREDIENT YOJ58O116E CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 PANCRELIPASE LIPASE ACTIVE INGREDIENT 8MYC33932O CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 PANCRELIPASE PROTEASE ACTIVE INGREDIENT 3560D81V50 CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 PANCRELIPASE AMYLASE ACTIVE MOIETY YOJ58O116E CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 PANCRELIPASE LIPASE ACTIVE MOIETY 8MYC33932O CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 PANCRELIPASE PROTEASE ACTIVE MOIETY 3560D81V50 CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 dimethicone INACTIVE INGREDIENT 92RU3N3Y1O CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 triethyl citrate INACTIVE INGREDIENT 8Z96QXD6UM CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-1212 CREON (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ATLANTIC BIOLOGICALS CORPS] 2 Legacy NDC, 1 package rows 20120529_45b9a46b-3294-4604-8aea-60624d663020.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 863841 CREON 12,000 UNT / 60,000 UNT / 38,000 UNT Delayed Release Oral Capsule PSN 45b9a46b-3294-4604-8aea-60624d663020 2 855503 lipase 12,000 UNT / amylase 60,000 UNT / protease 38,000 UNT Delayed Release Oral Capsule PSN 45b9a46b-3294-4604-8aea-60624d663020 2 863841 amylase 60000 UNT / lipase 12000 UNT / protease 38000 UNT Delayed Release Oral Capsule [Creon] SBD 45b9a46b-3294-4604-8aea-60624d663020 2 855503 amylase 60000 UNT / lipase 12000 UNT / protease 38000 UNT Delayed Release Oral Capsule SCD 45b9a46b-3294-4604-8aea-60624d663020 2 855503 amylase 60,000 UNT / lipase 12,000 UNT / protease 38,000 UNT Delayed Release Oral Capsule SY 45b9a46b-3294-4604-8aea-60624d663020 2 855503 amylases 60,000 UNT / endopeptidases 38,000 UNT / lipase 12,000 UNT Delayed Release Oral Capsule SY 45b9a46b-3294-4604-8aea-60624d663020 2 863841 Creon (amylases 60,000 UNT / endopeptidases 38,000 UNT / lipase 12,000 UNT) Delayed Release Oral Capsule SY 45b9a46b-3294-4604-8aea-60624d663020 2 863841 Creon 12 (amylase 60,000 UNT / lipase 12,000 UNT / protease 38,000 UNT) Delayed Release Oral Capsule SY 45b9a46b-3294-4604-8aea-60624d663020 2 863841 Creon 12,000 (lipase) Delayed Release Oral Capsule SY 45b9a46b-3294-4604-8aea-60624d663020 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 17856-1212-1 17856121201 1 in 1 POUCH Historical