Home NDC 0115-1752 Acitretin
Product NDC 0115-1752
11-digit product format 001151752
Labeler code 0115
Product ID 0115-1752_233bc68a-a24e-4f19-8477-3a11e80e68df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acitretin
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA202552
Marketing category ANDA
Marketing start 2016-01-04
Substance ACITRETIN
Active strength 22.5 mg/1
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0115-1752-08 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0115-1752-08 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0115-1752-08 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0115-1752-08 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0115-1752-08 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0115-1752-08 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0115-1752-08 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0115-1752-08 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0115-1752-08 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0115-1752-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0115-1752-08 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0115-1752-08 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 TE codes RLD / RS Approval date A202552-001 ACITRETIN ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 A202552-002 ACITRETIN ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 A202552-003 ACITRETIN ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 A202552-004 ACITRETIN ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23
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 · 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 A202552-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202552-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202552-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202552-004 ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202552-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202552-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202552-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202552-004 ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202552-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202552-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202552-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202552-004 ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202552-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202552-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202552-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202552-004 ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202552-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202552-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202552-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202552-004 ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202552-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202552-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202552-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202552-004 ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202552-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202552-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202552-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202552-004 ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202552-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202552-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202552-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202552-004 ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202552-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202552-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202552-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202552-004 ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202552-001 ACITRETIN 10MG CAPSULE / ORAL AB 2015-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202552-002 ACITRETIN 17.5MG CAPSULE / ORAL AB 2015-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202552-003 ACITRETIN 22.5MG CAPSULE / ORAL AB 2015-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202552-004 ACITRETIN 25MG CAPSULE / ORAL AB 2015-12-23 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Acitretin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACITRETIN 22.5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199689 Internal RxNorm lookup 199690 Internal RxNorm lookup 894859 Internal RxNorm lookup 894863 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 0115-1752-08 Acitretin 30 in 1 BOTTLE, PLASTIC CAPSULE 30 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-1752 ACITRETIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 17 Current NDC, Legacy NDC, 1 package rows 20231231_85507f6c-f802-479e-bacc-624b5136d092.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acitretin ACITRETIN Amneal Pharmaceuticals of New York LLC 85507f6c-f802-479e-bacc-624b5136d092 2024-01-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202552 application number: ANDA202552 ndc (product): 0115-1752
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 0115-1752-08 00115175208 30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1752-08) 30 capsule 2016-01-04 0000-00-00 No No Current