SORIATANE

Product NDC: 0145-0091
Requested package NDC: 0145-0091-25
11-digit product format: 001450091
Labeler code: 0145
Product ID: 0145-0091_d2549614-793c-41be-a0e7-b4fa9cee5845
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acitretin
Dosage form: CAPSULE
Route: ORAL
Labeler: Stiefel Laboratories Inc
Application: NDA019821
Marketing category: NDA
Marketing start: 1996-11-01
Marketing end: 2022-04-30
Substance: ACITRETIN
Active strength: 25 mg/1
Pharmacologic classes: Retinoid [EPC],Retinoids [CS]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0145-0091	0145-0091-25	D	Discontinued by firm		2026-08-03

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 · 12 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019821-001	SORIATANE	ACITRETIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28
N019821-002	SORIATANE	ACITRETIN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28
N019821-003	SORIATANE	ACITRETIN	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06
N019821-004	SORIATANE	ACITRETIN	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019821-001	SORIATANE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019821-002	SORIATANE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1996-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019821-003	SORIATANE	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019821-004	SORIATANE	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-08-06	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019821-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019821-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019821-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019821-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019821-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019821-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019821-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019821-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019821-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019821-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019821-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019821-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019821-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019821-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019821-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019821-002	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0145-0091-25	EA - Each	0145-0091	25c0436e-21b1-4ec1-877c-c3105f1621c3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACITRETIN	ACTIVE INGREDIENT	LCH760E9T7	SORIATANE (ACITRETIN) CAPSULE [STIEFEL LABORATORIES INC]	18
ACITRETIN	ACTIVE MOIETY	LCH760E9T7	SORIATANE (ACITRETIN) CAPSULE [STIEFEL LABORATORIES INC]	18
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SORIATANE (ACITRETIN) CAPSULE [STIEFEL LABORATORIES INC]	18
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SORIATANE (ACITRETIN) CAPSULE [STIEFEL LABORATORIES INC]	18
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SORIATANE (ACITRETIN) CAPSULE [STIEFEL LABORATORIES INC]	18
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SORIATANE (ACITRETIN) CAPSULE [STIEFEL LABORATORIES INC]	18
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SORIATANE (ACITRETIN) CAPSULE [STIEFEL LABORATORIES INC]	18
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SORIATANE (ACITRETIN) CAPSULE [STIEFEL LABORATORIES INC]	18
SODIUM ASCORBATE	INACTIVE INGREDIENT	S033EH8359	SORIATANE (ACITRETIN) CAPSULE [STIEFEL LABORATORIES INC]	18
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SORIATANE (ACITRETIN) CAPSULE [STIEFEL LABORATORIES INC]	18

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LCH760E9T7	ACITRETIN	55079-83-9	ACITRETIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0145-0091-25	00145009125	30 CAPSULE in 1 BOTTLE (0145-0091-25)	30 capsule	1996-11-01	2022-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SORIATANE (acitretin) Capsules	Stiefel Laboratories Inc	2018-10-08	HUMAN PRESCRIPTION DRUG LABEL	27