Home NDC 68308-666 ADAPALENE
Product NDC 68308-666
11-digit product format 683080666
Labeler code 68308
Product ID 68308-666_86366747-19bc-4279-8e62-afc7c8682e4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ADAPALENE
Dosage form GEL
Route TOPICAL
Labeler Mayne Pharma Commercial LLC.
Application NDA021753
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-02-26
Substance ADAPALENE
Active strength 3 mg/g
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 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 N021753-001 DIFFERIN ADAPALENE 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021753-001 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 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021753-001 DIFFERIN 0.3% GEL / TOPICAL AB RLD, RS 2007-06-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 5 · 170 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021753-001 7579377 2025-02-23 U-818 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021753-001 7579377 2025-02-23 U-818 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021753-001 7579377 2025-02-23 U-818 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021753-001 7579377 2025-02-23 U-818 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021753-001 7737181 2024-08-29 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021753-001 7579377 2025-02-23 U-818 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021753-001 7737181 2024-08-29 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021753-001 7579377 2025-02-23 U-818 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021753-001 7737181 2024-08-29 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021753-001 7579377 2025-02-23 U-818 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021753-001 7737181 2024-08-29 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021753-001 7579377 2025-02-23 U-818 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021753-001 7737181 2024-08-29 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021753-001 7579377 2025-02-23 U-818 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021753-001 7737181 2024-08-29 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021753-001 7579377 2025-02-23 U-818 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021753-001 7737181 2024-08-29 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021753-001 7579377 2025-02-23 U-818 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021753-001 7737181 2024-08-29 Drug product 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021753-001 7579377 2025-02-23 U-818 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021753-001 7737181 2024-08-29 Drug product 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021753-001 7579377 2025-02-23 U-818 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021753-001 7834060 2023-03-12 U-1078 2010-11-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021753-001 7838558 2023-03-12 Drug product 2010-11-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021753-001 7868044 2023-03-12 U-1078 2011-01-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021753-001 8703820 2023-03-12 U-1078 2014-05-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021753-001 7737181 2024-08-29 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021753-001 7579377 2025-02-23 U-818 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021753-001 7834060 2023-03-12 U-1078 2010-11-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021753-001 7838558 2023-03-12 Drug product 2010-11-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021753-001 7868044 2023-03-12 U-1078 2011-01-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021753-001 8703820 2023-03-12 U-1078 2014-05-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021753-001 7737181 2024-08-29 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021753-001 7579377 2025-02-23 U-818 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021753-001 7834060 2023-03-12 U-1078 2010-11-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021753-001 7838558 2023-03-12 Drug product 2010-11-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021753-001 7868044 2023-03-12 U-1078 2011-01-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021753-001 8703820 2023-03-12 U-1078 2014-05-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021753-001 7737181 2024-08-29 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021753-001 7579377 2025-02-23 U-818 4b0b4de00fa7…
Additional Listing Data#
Finished product Yes
Brand name base ADAPALENE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ADAPALENE 3 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 722111 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 68308-666-25 ADAPALENE 1 in 1 CARTON GEL 1 1 68308-666-25 ADAPALENE 45 g in 1 TUBE GEL 45 1 68308-666-45 ADAPALENE 45 g in 1 BOTTLE, PUMP GEL 45 1 68308-666-45 ADAPALENE 1 in 1 CARTON GEL 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68308-666 ADAPALENE GEL [MAYNE PHARMA COMMERCIAL LLC.] 1 Current NDC, 4 package rows 20240226_9a0d9a0d-a9f3-4eb9-be76-166ef182d13a.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68308-666-25 68308066625 1 TUBE in 1 CARTON (68308-666-25) / 45 g in 1 TUBE 1 tube 2024-02-26 No No Current 68308-666-45 68308066645 1 BOTTLE, PUMP in 1 CARTON (68308-666-45) / 45 g in 1 BOTTLE, PUMP 2024-02-26 No No Current