Home NDC 0168-0454 TAZAROTENE
Product NDC 0168-0454
11-digit product format 001680454
Labeler code 0168
Product ID 0168-0454_3c23d068-0930-45a1-87e2-ab0223d38b1a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tazarotene
Dosage form CREAM
Route TOPICAL
Labeler Fougera Pharmaceuticals Inc.
Application ANDA211175
Marketing category ANDA
Marketing start 2019-01-28
Marketing end 0000-00-00
Substance TAZAROTENE
Active strength 1 mg/g
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 · 57 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0168-0454-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0168-0454-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0168-0454-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0168-0454-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0168-0454-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0168-0454-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0168-0454-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0168-0454-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0168-0454-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0168-0454-60 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0168-0454-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0168-0454-60 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0168-0454-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0168-0454-60 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0168-0454-30 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0168-0454-60 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0168-0454-30 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0168-0454-60 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0168-0454-30 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0168-0454-60 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0168-0454-30 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0168-0454-60 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0168-0454-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0168-0454-60 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0168-0454-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0168-0454-60 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0168-0454-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0168-0454-60 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0168-0454-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0168-0454-60 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0168-0454-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0168-0454-60 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0168-0454-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0168-0454-60 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0168-0454-30 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0168-0454-60 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0168-0454-30 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0168-0454-60 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211175-001 TAZAROTENE TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL AB 2019-01-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211175-001 TAZAROTENE 0.1% CREAM / TOPICAL 2019-01-28 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-07-19 19:46 UTC 2019-07 A211175-001 AB 1 ea99ee380514…
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0168-0454-30 2024-07-11 These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997 0168-0454-60 2024-07-11 These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997 0168-0454-30 2021-07-23 These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997 0168-0454-60 2021-07-23 These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997 0168-0454-30 2020-09-18 These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997 0168-0454-60 2020-09-18 These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997 0168-0454-30 2020-07-22 These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997 0168-0454-60 2020-07-22 These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM. TAZAROTENE cream, for topical use Initial U.S. Approval: 1997
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0168-0454-30 00168045430 1 TUBE in 1 CARTON (0168-0454-30) > 30 g in 1 TUBE 1 tube 2019-01-28 0000-00-00 No No Current 0168-0454-60 00168045460 1 TUBE in 1 CARTON (0168-0454-60) > 60 g in 1 TUBE 1 tube 2019-01-28 0000-00-00 No No Current