TRETINOIN

Product NDC
50090-3090
11-digit product format
500903090
Labeler code
50090
Product ID
50090-3090_638016c6-aa85-409d-bcf4-e72c7176cc91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA075213
Marketing category
ANDA
Marketing start
2017-03-30
Marketing end
0000-00-00
Substance
TRETINOIN
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3090DDiscontinued by firm2026-08-03
excluded packagepackage50090-309050090-3090-0DDiscontinued by firm2026-08-03

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 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3090-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3090-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3090-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3090-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3090-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3090-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3090-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3090-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3090-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3090-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3090-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3090-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-3090-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-3090-0IInactivated by FDA9bebd1f3094a…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075213-001TRETINOINTRETINOIN0.1%CREAM / TOPICALAB1998-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A075213-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-243f01610625f2…
2019-09-15 20:21 UTC2019-09A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075213-001TRETINOIN0.1%CREAM / TOPICALAB1998-12-24cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075213-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075213-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075213-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075213-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075213-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075213-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075213-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075213-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075213-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075213-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075213-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075213-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075213-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075213-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075213-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075213-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075213-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075213-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075213-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075213-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075213-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075213-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075213-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075213-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075213-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075213-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075213-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075213-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075213-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075213-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075213-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075213-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075213-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075213-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075213-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075213-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075213-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075213-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075213-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075213-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3090-0TRETINOIN45 g in 1 TUBECREAM4524
50090-3090-0TRETINOIN1 in 1 CARTONCREAM124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3090-0GM - Gram50090-30906f87f60e-6567-40b2-964d-16e08d4e9ba712018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3090TRETINOIN CREAM [A-S MEDICATION SOLUTIONS]24Legacy NDC, 2 package rows20241025_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRETINOINTRETINOINREMEDYREPACK INC.c4d5155b-046d-4f94-bafc-651b572c2bd52026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075213
application number: ANDA075213
TRETINOINTRETINOINA-S Medication Solutions0a6722ba-c2e5-4d7a-82ea-bcd6a54033b52024-01-28Warnings, Adverse reactionsExact identifier
ndc (product): 50090-3090
TRETINOINTRETINOINPadagis US LLC4889c7f8-37d0-4f1a-9829-bca1078065862023-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075213
application number: ANDA075213

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSN0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106303tretinoin 0.05 % Topical CreamPSN0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
198300tretinoin 0.1 % Topical CreamPSN0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106302tretinoin 0.25 MG/ML Topical CreamSCD0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106303tretinoin 0.5 MG/ML Topical CreamSCD0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
198300tretinoin 1 MG/ML Topical CreamSCD0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106302tretinoin 0.025 % Topical CreamSY0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106303tretinoin 0.05 % Topical CreamSY0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
198300tretinoin 0.1 % Topical CreamSY0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50090-3090-05009030900045 g in 1 TUBE45 gHistorical