Home NDC 0168-0424 Adapalene
Product NDC 0168-0424
11-digit product format 001680424
Labeler code 0168
Product ID 0168-0424_3704e230-6ad8-448d-a4bf-a86c449837b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name adapalene
Dosage form CREAM
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application ANDA090824
Marketing category ANDA
Marketing start 2010-06-30
Substance ADAPALENE
Active strength 1 mg/g
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A090824-001 ADAPALENE ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090824-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090824-001 ADAPALENE 0.1% CREAM / TOPICAL AB 2010-06-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Adapalene
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ADAPALENE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1L4806J2QF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313852 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0168-0424-46 Adapalene 1 in 1 CARTON CREAM 1 10 0168-0424-46 Adapalene 45 g in 1 TUBE CREAM 45 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ADAPALENE ACTIVE INGREDIENT 1L4806J2QF ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 ADAPALENE ACTIVE MOIETY 1L4806J2QF ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 CYCLOMETHICONE INACTIVE INGREDIENT NMQ347994Z ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 SQUALENE INACTIVE INGREDIENT 7QWM220FJH ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 6 ADAPALENE ACTIVE INGREDIENT 1L4806J2QF ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 ADAPALENE ACTIVE MOIETY 1L4806J2QF ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 CARBOMER 934 INACTIVE INGREDIENT Z135WT9208 ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 CYCLOMETHICONE INACTIVE INGREDIENT NMQ347994Z ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 SQUALANE INACTIVE INGREDIENT GW89575KF9 ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ADAPALENE CREAM [PHYSICIANS TOTAL CAER, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0424 ADAPALENE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 2 package rows 20240821_276f7cce-5f54-40f8-8321-9192d0e52a73.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.
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 0168-0424-46 00168042446 1 TUBE in 1 CARTON (0168-0424-46) / 45 g in 1 TUBE 1 tube 2010-06-30 0000-00-00 No No Current