Home NDC 50090-3058 TRETINOIN
Product NDC 50090-3058
11-digit product format 500903058
Labeler code 50090
Product ID 50090-3058_751edf37-8105-49e3-8621-475a5543193b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tretinoin
Dosage form CREAM
Route TOPICAL
Labeler A-S Medication Solutions
Application ANDA075265
Marketing category ANDA
Marketing start 2017-04-26
Substance TRETINOIN
Active strength .5 mg/g
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 · 14 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 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 50090-3058-0 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 50090-3058-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-3058-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-3058-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-3058-0 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 50090-3058-0 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 50090-3058-0 9bebd1f3094a…5416666fcb17…
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 A075265-001 TRETINOIN TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075265-001 AB1
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 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075265-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 1998-12-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TRETINOIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRETINOIN .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5688UTC01R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106302 Internal RxNorm lookup 106303 Internal RxNorm lookup 198300 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3058-0 TRETINOIN 45 g in 1 TUBE CREAM 45 24 50090-3058-0 TRETINOIN 1 in 1 CARTON CREAM 1 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3058 TRETINOIN CREAM [A-S MEDICATION SOLUTIONS] 24 Current NDC, Legacy NDC, 2 package rows 20241025_0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5.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 · 3 matching rows.
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 50090-3058-0 50090305800 1 TUBE in 1 CARTON (50090-3058-0) / 45 g in 1 TUBE 1 tube 2017-06-15 0000-00-00 No No Current