Home NDC 42794-081 ACITRETIN
Product NDC 42794-081
11-digit product format 427940081
Labeler code 42794
Product ID 42794-081_57aea59c-767d-0301-e063-6294a90a9d9a
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 17.5 mg/1
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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.
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 · 176 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 2026-10-15 13:18:30 2026-09 A204633-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204633-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204633-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204633-004 ACITRETIN 25MG CAPSULE / ORAL AB RS 2015-05-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204633-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204633-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204633-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204633-004 ACITRETIN 25MG CAPSULE / ORAL AB RS 2015-05-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204633-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204633-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204633-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204633-004 ACITRETIN 25MG CAPSULE / ORAL AB RS 2015-05-22 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ACITRETIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACITRETIN 17.5 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42794-081-08 ACITRETIN 30 in 1 BOTTLE CAPSULE 30 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 42794-081 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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ACITRETIN ACITRETIN Sigmapharm Laboratories, LLC a6546625-acb8-460e-b34e-f795bfb3680a 2026-08-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204633 application number: ANDA204633 ndc (product): 42794-081 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42794-081-08 42794008108 30 CAPSULE in 1 BOTTLE (42794-081-08) 30 capsule 2015-09-16 0000-00-00 No No Current