54809-1025-8

Product NDC: 54809-1025
Requested package NDC: 54809-1025-8
11-digit product format: 548091025
Labeler code: 54809
Product ID: 54809-1025_4e6c02cd-dcf0-271e-e063-6394a90a2f71
Type: BULK INGREDIENT
Nonproprietary name: Pancrelipase
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Marketing category: EXPORT ONLY
Marketing start: 2013-10-21
Substance: PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE
Active strength: 24000 [USP'U]/1; 76000 [USP'U]/1; 120000 [USP'U]/1
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	54809-1025	54809-1025-8	UNFINISHED	Active or certified unfinished drug listing		2026-10-15

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 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: No
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PANCRELIPASE LIPASE	24000 [USP'U]/1
PANCRELIPASE PROTEASE	76000 [USP'U]/1
PANCRELIPASE AMYLASE	120000 [USP'U]/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b1603b8-969e-b082-f6f5-ad66d8a6ea8a	Product name	2	20200325
19041f15-771b-3d3a-88fc-f5e2d079cd6d	Product name	2	20200325
1987d950-08e4-4b70-adeb-fb67a71142ab	Product name	2	20200325
8825ddf7-1520-4680-b0ee-684e2fa73672	Product name	2	20200325
267a6f34-90b4-2f48-3063-4f505d06a7be	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-08-01	Creon Bulk Caspules
2025-08-01	Creon Bulk Caspules
2025-07-29	Creon Bulk Caspules
2025-07-29	Creon Bulk Caspules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54809-1025-8	Creon 24000	44000 in 1 DRUM	CAPSULE, DELAYED RELEASE PELLETS	44000		16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54809-1025	CREON 24000 (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON 3000 (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON 6000 (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON 12000 (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS CREON 36000 (PANCRELIPASE) CAPSULE, DELAYED RELEASE PELLETS [ABBOTT LABORATORIES GMBH]	14	1 package rows	20241207_c29a4461-377f-402f-9f86-7b03f1be2aa4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8MYC33932O	PANCRELIPASE LIPASE	9001-62-1	PANCRELIPASE LIPASE
3560D81V50	PANCRELIPASE PROTEASE	9001-94-9	PANCRELIPASE PROTEASE
YOJ58O116E	PANCRELIPASE AMYLASE	9000-90-2	PANCRELIPASE AMYLASE
FQ3DRG0N5K	PANCRELIPASE	53608-75-6	Pancrelipase

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
54809-1025-8	54809102508	44000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM (54809-1025-8)	07-DEC-21	Current