Home NDC 0682-0053 Adapalene Topical Solution
Product NDC 0682-0053
11-digit product format 006820053
Labeler code 0682
Product ID 0682-0053_804c7131-c45c-e558-e053-2991aa0a291c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adapalene
Dosage form SWAB
Route TOPICAL
Labeler Marnel Pharmaceuticals, Inc.
Application ANDA204593
Marketing category ANDA
Marketing start 2018-08-27
Marketing end 0000-00-00
Substance ADAPALENE
Active strength 1 mg/mL
Pharmacologic classes Retinoid [EPC],Retinoids [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 A204593-001 ADAPALENE ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204593-001 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 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0682-0053-14 2020-10-22 PLIXDA (Adapalene) Topical Solution, 0.1% 0682-0053-30 2020-10-22 PLIXDA (Adapalene) Topical Solution, 0.1% 0682-0053-14 2020-09-27 PLIXDA (Adapalene) Topical Solution, 0.1% 0682-0053-30 2020-09-27 PLIXDA (Adapalene) Topical Solution, 0.1% 0682-0053-14 2020-09-25 PLIXDA (Adapalene) Topical Solution, 0.1% 0682-0053-30 2020-09-25 PLIXDA (Adapalene) Topical Solution, 0.1% 0682-0053-14 2020-07-22 PLIXDA (Adapalene) Topical Solution, 0.1% 0682-0053-30 2020-07-22 PLIXDA (Adapalene) Topical Solution, 0.1%
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Adapalene ADAPALENE CALL INC. (dba Rochester Pharmaceuticals) 5ce78048-0e5c-45b5-82bf-9f61307611cd 2025-01-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 204593 application number: ANDA204593