Stozyme

Product NDC: 72850-0004
Requested package NDC: 72850-0004-1
11-digit product format: 728500004
Labeler code: 72850
Product ID: 72850-0004_96932453-80c3-4a44-e053-2a95a90a7bb6
Type: HUMAN OTC DRUG
Nonproprietary name: pancreatin, hemicellulase, OX bile extract, dimethicone
Dosage form: TABLET
Route: ORAL
Labeler: Chunwoo Pharmaceutical Co., Ltd.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2019-10-19
Marketing end: 0000-00-00
Substance: HEMICELLULASE (ASPERGILLUS NIGER); DIMETHICONE; PANCRELIPASE; BOS TAURUS BILE
Active strength: 10 1/1001; 1/1001; 1/1001; 1/1001
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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
excluded package	package	72850-0004	72850-0004-1	I	Inactivated by FDA		2026-10-05

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 · 15 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72850-0004-1	2024-01-30	C162847	48780-1	1030e365-4b70-111a-e063-dadaa90a10e2	96932453-80c2-4a44-e053-2a95a90a7bb6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72850-0004-1	Stozyme	10 in 1 BLISTER PACK	TABLET	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72850-0004	STOZYME (PANCREATIN, HEMICELLULASE, OX BILE EXTRACT, DIMETHICONE) TABLET [CHUNWOO PHARMACEUTICAL CO., LTD.]	1	Legacy NDC, 1 package rows	20191105_96932453-80c2-4a44-e053-2a95a90a7bb6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE
FQ3DRG0N5K	PANCRELIPASE	53608-75-6	PANCRELIPASE
ET3651ZLOU	BOS TAURUS BILE		BOS TAURUS BILE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72850-0004-1	72850000401	10 TABLET in 1 BLISTER PACK (72850-0004-1)	10 tablet	2019-10-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Stozyme - Chunwoo Pharmaceutical Co., Ltd.	Chunwoo Pharmaceutical Co., Ltd.	2019-11-04	HUMAN OTC DRUG LABEL	1