Picato

Product NDC
50222-503
11-digit product format
502220503
Labeler code
50222
Product ID
50222-503_250a62f1-8f42-4306-884b-78c6f906988b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ingenol mebutate
Dosage form
GEL
Route
TOPICAL
Labeler
LEO Pharma Inc.
Application
NDA202833
Marketing category
NDA
Marketing start
2012-01-23
Marketing end
2022-04-30
Substance
INGENOL MEBUTATE
Active strength
500 ug/g
Pharmacologic classes
Cell Death Inducer [EPC],Increased Cellular Death [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50222-503DDiscontinued by firm2026-10-05
excluded packagepackage50222-50350222-503-47DDiscontinued by firm2026-10-05
excluded packagepackage50222-50350222-503-92DDiscontinued by firm2026-10-05

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50222-503-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50222-503-47d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50222-503-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50222-503-47f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50222-503-922ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50222-503-472ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50222-503-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50222-503-47a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50222-503-92cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50222-503-47cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50222-503-92cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50222-503-47cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50222-503-92302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50222-503-47302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50222-503-92ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50222-503-47ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50222-503-920efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50222-503-470efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50222-503-92ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50222-503-47ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50222-503-92367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50222-503-47367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50222-503-92557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50222-503-47557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202833-001PICATOINGENOL MEBUTATE0.015%GEL / TOPICALRLD2012-01-23
N202833-002PICATOINGENOL MEBUTATE0.05%GEL / TOPICALRLD2012-01-23

Orange Book patents#

Current patent rows page 1 of 1 · 23 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202833-00183728272026-12-18Drug product2013-03-08
N202833-00183728282026-12-18Drug product2013-03-08
N202833-00183779192026-12-18Drug product2013-03-08
N202833-00185361632026-12-18U-14402013-10-15
N202833-00187162712026-12-18U-14402014-05-28
N202833-00187353752026-12-18U-14402014-06-26
N202833-00198209592026-12-18U-1440Drug product2017-11-22
N202833-00198334282026-12-18Drug product2017-12-06
N202833-00198334292026-12-18Drug product2017-12-06
N202833-00198616032026-12-18U-14402018-01-16
N202833-00182782922027-07-06Drug product2012-10-23
N202833-00197890782033-05-15U-21382017-11-15
N202833-00283728272026-12-18Drug product
N202833-00283728282026-12-18Drug product
N202833-00283779192026-12-18Drug product
N202833-00285361632026-12-18U-14402013-10-15
N202833-00287162712026-12-18U-14402014-05-28
N202833-00287353752026-12-18U-14402014-06-26
N202833-00298209592026-12-18U-1440Drug product2017-11-22
N202833-00298334282026-12-18Drug product2017-12-06
N202833-00298334292026-12-18Drug product2017-12-06
N202833-00298616032026-12-18U-14402018-01-16
N202833-00282782922027-07-06Drug product

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-2384e616aacf4f…
2026-09-14 22:38:342026-08N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-2384e616aacf4f…
2026-08-18 06:07:402026-07N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202833-001PICATO0.015%GEL / TOPICALRLD2012-01-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N202833-002PICATO0.05%GEL / TOPICALRLD2012-01-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202833-001PICATO0.015%GEL / TOPICALABRLD, RS2012-01-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202833-002PICATO0.05%GEL / TOPICALABRLD, RS2012-01-2374a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N202833-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202833-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N202833-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N202833-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N202833-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N202833-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N202833-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N202833-002AB1ea99ee380514…

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,001 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N202833-00183728272026-12-18Drug product2013-03-0884e616aacf4f…
2026-09-14 22:38:342026-08N202833-00183728282026-12-18Drug product2013-03-0884e616aacf4f…
2026-09-14 22:38:342026-08N202833-00183779192026-12-18Drug product2013-03-0884e616aacf4f…
2026-09-14 22:38:342026-08N202833-00185361632026-12-18U-14402013-10-1584e616aacf4f…
2026-09-14 22:38:342026-08N202833-00187162712026-12-18U-14402014-05-2884e616aacf4f…
2026-09-14 22:38:342026-08N202833-00187353752026-12-18U-14402014-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N202833-00198209592026-12-18U-1440Drug product2017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08N202833-00198334282026-12-18Drug product2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08N202833-00198334292026-12-18Drug product2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08N202833-00198616032026-12-18U-14402018-01-1684e616aacf4f…
2026-09-14 22:38:342026-08N202833-00182782922027-07-06Drug product2012-10-2384e616aacf4f…
2026-09-14 22:38:342026-08N202833-00197890782033-05-15U-21382017-11-1584e616aacf4f…
2026-09-14 22:38:342026-08N202833-00283728272026-12-18Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N202833-00283728282026-12-18Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N202833-00283779192026-12-18Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N202833-00285361632026-12-18U-14402013-10-1584e616aacf4f…
2026-09-14 22:38:342026-08N202833-00287162712026-12-18U-14402014-05-2884e616aacf4f…
2026-09-14 22:38:342026-08N202833-00287353752026-12-18U-14402014-06-2684e616aacf4f…
2026-09-14 22:38:342026-08N202833-00298209592026-12-18U-1440Drug product2017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08N202833-00298334282026-12-18Drug product2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08N202833-00298334292026-12-18Drug product2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08N202833-00298616032026-12-18U-14402018-01-1684e616aacf4f…
2026-09-14 22:38:342026-08N202833-00282782922027-07-06Drug product84e616aacf4f…
2026-08-18 06:07:402026-07N202833-00183728272026-12-18Drug product2013-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00183728282026-12-18Drug product2013-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00183779192026-12-18Drug product2013-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00185361632026-12-18U-14402013-10-15caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00187162712026-12-18U-14402014-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00187353752026-12-18U-14402014-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00198209592026-12-18U-1440Drug product2017-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00198334282026-12-18Drug product2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00198334292026-12-18Drug product2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00198616032026-12-18U-14402018-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00182782922027-07-06Drug product2012-10-23caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00197890782033-05-15U-21382017-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00283728272026-12-18Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00283728282026-12-18Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00283779192026-12-18Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00285361632026-12-18U-14402013-10-15caaa826d4ba7…
2026-08-18 06:07:402026-07N202833-00287162712026-12-18U-14402014-05-28caaa826d4ba7…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50222-503-47EA - Each50222-5035f7b0245-77de-4c1c-966e-38f59b6d42af12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ingenol mebutateACTIVE INGREDIENT7686S50JAHPICATO (INGENOL MEBUTATE) GEL [LEO PHARMA INC.]5
ingenol mebutateACTIVE MOIETY7686S50JAHPICATO (INGENOL MEBUTATE) GEL [LEO PHARMA INC.]5
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHPICATO (INGENOL MEBUTATE) GEL [LEO PHARMA INC.]5
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPPICATO (INGENOL MEBUTATE) GEL [LEO PHARMA INC.]5
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16PICATO (INGENOL MEBUTATE) GEL [LEO PHARMA INC.]5
isopropyl alcoholINACTIVE INGREDIENTND2M416302PICATO (INGENOL MEBUTATE) GEL [LEO PHARMA INC.]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPICATO (INGENOL MEBUTATE) GEL [LEO PHARMA INC.]5
waterINACTIVE INGREDIENT059QF0KO0RPICATO (INGENOL MEBUTATE) GEL [LEO PHARMA INC.]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50222-503-47502220503472 TUBE in 1 CARTON (50222-503-47) > .47 g in 1 TUBE2 tube2012-01-232022-04-30NoNoCurrent
50222-503-92502220503922 TUBE in 1 CARTON (50222-503-92) > .47 g in 1 TUBE2 tube2012-01-232022-04-30NoNoCurrent