Home NDC 51672-2143 Adapalene
Product NDC 51672-2143
11-digit product format 516722143
Labeler code 51672
Product ID 51672-2143_740cf78a-9728-4245-9ca2-448d2c9a997d
Type HUMAN OTC DRUG
Nonproprietary name Adapalene
Dosage form GEL
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA215940
Marketing category ANDA
Marketing start 2022-01-14
Marketing end 0000-00-00
Substance ADAPALENE
Active strength 1 mg/g
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 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 A215940-001 ADAPALENE ADAPALENE 0.1% GEL / TOPICAL 2022-01-14
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.
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 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 a50c72e98297…
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 · 12 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 51672-2143-1 51672214301 1 TUBE in 1 CARTON (51672-2143-1) > 15 g in 1 TUBE 1 tube 2022-01-14 0000-00-00 No No Current 51672-2143-6 51672214306 1 TUBE in 1 CARTON (51672-2143-6) > 45 g in 1 TUBE 1 tube 2022-01-14 0000-00-00 No No Current