Home NDC 68084-075 Tretinoin
Product NDC 68084-075
11-digit product format 680840075
Labeler code 68084
Product ID 68084-075_41c2a834-9f5a-9820-e063-6294a90ad914
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tretinoin
Dosage form CAPSULE
Route ORAL
Labeler American Health Packaging
Application ANDA201687
Marketing category ANDA
Marketing start 2013-07-18
Substance TRETINOIN
Active strength 10 mg/1
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A201687-001 TRETINOIN TRETINOIN 10MG CAPSULE / ORAL AB RS 2012-10-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201687-001 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 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB RS 2012-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB RS 2012-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB RS 2012-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB RS 2012-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 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 10 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199159 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68084-075-11 Tretinoin 10 in 1 BLISTER PACK CAPSULE 10 7 68084-075-21 Tretinoin 3 in 1 CARTON CAPSULE 3 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-075 TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 Current NDC, Legacy NDC, 2 package rows 20241031_b22d5a07-623a-4645-b87d-a151b86da8d5.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tretinoin TRETINOIN Major Pharmaceuticals 045258e2-5efb-4147-bf74-4c43af04dccc 2026-05-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201687 application number: ANDA201687 Tretinoin TRETINOIN Par Health USA, LLC 9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9 2026-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201687 application number: ANDA201687 Tretinoin TRETINOIN American Health Packaging b22d5a07-623a-4645-b87d-a151b86da8d5 2025-10-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201687 application number: ANDA201687 ndc (product): 68084-075 Tretinoin TRETINOIN Bryant Ranch Prepack 7a7974c7-8b6c-41ae-9a48-a08a1439087a 2024-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201687 application number: ANDA201687
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 68084-075-11 68084007511 10 in 1 BLISTER PACK Historical 68084-075-21 68084007521 3 BLISTER PACK in 1 CARTON (68084-075-21) / 10 CAPSULE in 1 BLISTER PACK (68084-075-11) 3 blister pack 2013-07-18 0000-00-00 No No Current