ACITRETIN

Product NDC: 42794-080
11-digit product format: 427940080
Labeler code: 42794
Product ID: 42794-080_f1f1dd05-77f9-ff40-e053-2995a90a2e80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACITRETIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Sigmapharm Laboratories, LLC
Application: ANDA204633
Marketing category: ANDA
Marketing start: 2015-09-16
Substance: ACITRETIN
Active strength: 10 mg/1
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	TE codes	RLD / RS	Approval date
A204633-001	ACITRETIN	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22
A204633-002	ACITRETIN	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22
A204633-003	ACITRETIN	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22
A204633-004	ACITRETIN	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204633-001	AB
A204633-002	AB
A204633-003	AB
A204633-004	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204633-001	ACITRETIN	10MG	CAPSULE / ORAL	AB		2015-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-002	ACITRETIN	17.5MG	CAPSULE / ORAL	AB		2015-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-003	ACITRETIN	22.5MG	CAPSULE / ORAL	AB		2015-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-004	ACITRETIN	25MG	CAPSULE / ORAL	AB	RS	2015-05-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204633-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204633-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204633-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204633-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204633-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204633-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204633-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204633-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204633-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204633-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204633-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204633-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204633-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: ACITRETIN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACITRETIN	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LCH760E9T7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199689	Internal RxNorm lookup
199690	Internal RxNorm lookup
894859	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a6546625-acb8-460e-b34e-f795bfb3680a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1de339d8-426e-ddd1-e402-3d0883adaab0	Product name	6	20250312

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42794-080-08	ACITRETIN	30 in 1 BOTTLE	CAPSULE	30		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42794-080-08	EA - Each	42794-080	b5515053-a357-4051-b8d7-4470b340ea8a	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACITRETIN	ACTIVE INGREDIENT	LCH760E9T7	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3
ACITRETIN	ACTIVE MOIETY	LCH760E9T7	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3
SODIUM ASCORBATE	INACTIVE INGREDIENT	S033EH8359	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42794-080	ACITRETIN CAPSULE [SIGMAPHARM LABORATORIES, LLC]	7	Current NDC, Legacy NDC, 1 package rows	20230111_a6546625-acb8-460e-b34e-f795bfb3680a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACITRETIN	ACITRETIN	Bryant Ranch Prepack	1e87e415-070d-41f5-9d93-17793e8ad8a6	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204633 application number: ANDA204633
ACITRETIN	ACITRETIN	Bryant Ranch Prepack	08ce9fdd-1e84-4043-b085-91053f975b64	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204633 application number: ANDA204633
ACITRETIN	ACITRETIN	Bryant Ranch Prepack	a5be620f-d721-40c1-a062-d21c70bfcbed	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204633 application number: ANDA204633
ACITRETIN	ACITRETIN	AvKARE	6af396c2-af3e-436d-ba9a-583637495910	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204633 application number: ANDA204633
ACITRETIN	ACITRETIN	Sigmapharm Laboratories, LLC	a6546625-acb8-460e-b34e-f795bfb3680a	2023-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204633 application number: ANDA204633 ndc (product): 42794-080

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199689	acitretin 10 MG Oral Capsule	PSN	08ce9fdd-1e84-4043-b085-91053f975b64	101
199689	acitretin 10 MG Oral Capsule	SCD	08ce9fdd-1e84-4043-b085-91053f975b64	101
199689	acitretin 10 MG Oral Capsule	PSN	a6546625-acb8-460e-b34e-f795bfb3680a	7
894859	acitretin 17.5 MG Oral Capsule	PSN	a6546625-acb8-460e-b34e-f795bfb3680a	7
199690	acitretin 25 MG Oral Capsule	PSN	a6546625-acb8-460e-b34e-f795bfb3680a	7
199689	acitretin 10 MG Oral Capsule	SCD	a6546625-acb8-460e-b34e-f795bfb3680a	7
894859	acitretin 17.5 MG Oral Capsule	SCD	a6546625-acb8-460e-b34e-f795bfb3680a	7
199690	acitretin 25 MG Oral Capsule	SCD	a6546625-acb8-460e-b34e-f795bfb3680a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42794-080-08	42794008008	30 CAPSULE in 1 BOTTLE (42794-080-08)	30 capsule	2015-09-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
® Tablets	Bryant Ranch Prepack	2024-01-26	HUMAN PRESCRIPTION DRUG LABEL	101
ACITRETIN - Sigmapharm Laboratories, LLC	Sigmapharm Laboratories, LLC	2023-01-10	HUMAN PRESCRIPTION DRUG LABEL	7