Home NDC 0472-0126 adapalene
Product NDC 0472-0126
11-digit product format 004720126
Labeler code 0472
Product ID 0472-0126_9bada4fd-f276-4355-bed1-ae5eee087c95
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name adapalene
Dosage form GEL
Route TOPICAL
Labeler Actavis Pharma, Inc.
Application ANDA201000
Marketing category ANDA
Marketing start 2014-10-27
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 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 A201000-001 ADAPALENE ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201000-001 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 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201000-001 ADAPALENE 0.3% GEL / TOPICAL AB 2014-10-27 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 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 0472-0126-45 adapalene 45 g in 1 TUBE GEL 45 8 0472-0126-45 adapalene 1 in 1 CARTON GEL 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ADAPALENE ACTIVE INGREDIENT 1L4806J2QF ADAPALENE GEL [ACTAVIS PHARMA, INC.] 2 ADAPALENE ACTIVE MOIETY 1L4806J2QF ADAPALENE GEL [ACTAVIS PHARMA, INC.] 2 CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 4Q93RCW27E ADAPALENE GEL [ACTAVIS PHARMA, INC.] 2 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU ADAPALENE GEL [ACTAVIS PHARMA, INC.] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB ADAPALENE GEL [ACTAVIS PHARMA, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ADAPALENE GEL [ACTAVIS PHARMA, INC.] 2 POLOXAMER 182 INACTIVE INGREDIENT JX0HIX6OAG ADAPALENE GEL [ACTAVIS PHARMA, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ADAPALENE GEL [ACTAVIS PHARMA, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ADAPALENE GEL [ACTAVIS PHARMA, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ADAPALENE GEL [ACTAVIS PHARMA, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0472-0126 ADAPALENE GEL [ACTAVIS PHARMA, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240617_aacd5ec4-e2fa-460e-aaae-a0aba5c052e5.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 · 1 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 0472-0126-45 00472012645 1 TUBE in 1 CARTON (0472-0126-45) / 45 g in 1 TUBE 1 tube 2014-10-27 0000-00-00 No No Current