Home NDC 0115-1698-08 Acitretin
Product NDC 0115-1698
Requested package NDC 0115-1698-08
11-digit product format 001151698
Labeler code 0115
Product ID 0115-1698_f90efecb-4027-4dee-8d7a-b6ec1ac8c762
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
Marketing end 0000-00-00
Substance ACITRETIN
Active strength 23 mg/1
Pharmacologic classes Retinoid [EPC],Retinoids [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 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.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0115-1698-08 00115169808 30 CAPSULE in 1 BOTTLE, PLASTIC (0115-1698-08) 30 capsule 2016-01-04 0000-00-00 No No Current