Home NDC 0378-6141-45 Avita
Product NDC 0378-6141
Requested package NDC 0378-6141-45
11-digit product format 003786141
Labeler code 0378
Product ID 0378-6141_47cd24e0-9531-40f8-8a1c-d313de7f83a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tretinoin
Dosage form CREAM
Route TOPICAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA020404
Marketing category NDA
Marketing start 1997-06-01
Marketing end 0000-00-00
Substance TRETINOIN
Active strength 0 mg/g
Pharmacologic classes Retinoid [EPC],Retinoids [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020404-003 AVITA TRETINOIN 0.025% CREAM / TOPICAL AB 1997-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020404-003 AB
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 · 41 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 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020404-003 AVITA 0.025% CREAM / TOPICAL AB 1997-01-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-6141-45 00378614145 45 g in 1 TUBE (0378-6141-45) 45 g 1997-06-01 0000-00-00 No No Current