Home NDC 46708-742 Acitretin
Product NDC 46708-742
11-digit product format 467080742
Labeler code 46708
Product ID 46708-742_77011f2b-a2e7-4a43-9ff3-29d73f322319
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acitretin
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA217774
Marketing category ANDA
Marketing start 2024-08-08
Substance ACITRETIN
Active strength 17.5 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217774-001 ACITRETIN ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 A217774-002 ACITRETIN ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 A217774-003 ACITRETIN ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
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 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217774-001 ACITRETIN 10MG CAPSULE / ORAL AB 2024-08-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217774-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2024-08-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217774-003 ACITRETIN 25MG CAPSULE / ORAL AB 2024-08-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Acitretin
Listing expiration 2026-12-31 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 46708-742-30 Acitretin 30 in 1 BOTTLE CAPSULE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-742 ACITRETIN CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 1 package rows 20240810_77011f2b-a2e7-4a43-9ff3-29d73f322319.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46708-742-30 46708074230 30 CAPSULE in 1 BOTTLE (46708-742-30) 30 capsule 2024-08-08 No No Current