Home NDC 0093-1138-00 Acitretin
Product NDC 0093-1138
Requested package NDC 0093-1138-00
11-digit product format 000931138
Labeler code 0093
Product ID 0093-1138_11579624-a4a1-4db1-bf72-9fbedbce3225
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acitretin
Dosage form CAPSULE
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA202897
Marketing category ANDA
Marketing start 2013-07-19
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 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 · 16 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 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202897-001 ACITRETIN ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 A202897-002 ACITRETIN ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202897-001 ACITRETIN 17.5MG CAPSULE / ORAL AB 2013-04-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202897-002 ACITRETIN 22.5MG CAPSULE / ORAL AB 2013-04-04 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 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 0093-1138-56 Acitretin 30 in 1 BOTTLE CAPSULE 30 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-1138 ACITRETIN CAPSULE [TEVA PHARMACEUTICALS USA, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20220911_993a5325-cd10-4450-b5ea-1c0a90510df6.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 0093-1138-00 00093113800 13000 CAPSULE in 1 BOX (0093-1138-00) 13000 capsule 01-NOV-21 Current