Home NDC 43478-241 Tretinoin
Product NDC 43478-241
11-digit product format 434780241
Labeler code 43478
Product ID 43478-241_a61787f3-f3c8-4ea7-b659-f1ba1655336b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tretinoin
Dosage form CREAM
Route TOPICAL
Labeler Rouses Point
Application ANDA075213
Marketing category ANDA
Marketing start 1998-12-24
Marketing end 2019-08-01
Substance TRETINOIN
Active strength 1 mg/g
Pharmacologic classes Retinoid [EPC],Retinoids [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A075213-001 TRETINOIN TRETINOIN 0.1% CREAM / TOPICAL AB 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 A075213-001 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 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075213-001 TRETINOIN 0.1% CREAM / TOPICAL AB 1998-12-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRETINOIN ACTIVE INGREDIENT 5688UTC01R TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1 TRETINOIN ACTIVE INGREDIENT 5688UTC01R TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 TRETINOIN ACTIVE MOIETY 5688UTC01R TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 TRETINOIN ACTIVE MOIETY 5688UTC01R TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 NITROGEN INACTIVE INGREDIENT N762921K75 TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TRETINOIN CREAM [DISPENSING SOLUTIONS, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TRETINOIN CREAM [REBEL DISTRIBUTORS CORP] 1
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.
DailyMed RxNorm Mappings#