Home NDC 45802-453 Adapalene
Product NDC 45802-453
11-digit product format 458020453
Labeler code 45802
Product ID 45802-453_0a564c3c-85dd-4fb8-8bb8-27a9e24c5723
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adapalene
Dosage form CREAM
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application NDA020748
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2010-10-26
Substance ADAPALENE
Active strength .1 g/100g
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 N020748-001 DIFFERIN ADAPALENE 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020748-001 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 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020748-001 DIFFERIN 0.1% CREAM / TOPICAL AB RLD, RS 2000-05-26 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 .1 g/100g
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45802-453-84 Adapalene 45 g in 1 TUBE CREAM 45 4 45802-453-84 Adapalene 1 in 1 CARTON CREAM 1 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-453 ADAPALENE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] 4 Current NDC, Legacy NDC, 2 package rows 20230801_94cf9af1-afab-4064-a2ca-619b54218262.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 45802-453-84 45802045384 1 TUBE in 1 CARTON (45802-453-84) / 45 g in 1 TUBE 1 tube 2010-10-27 0000-00-00 No No Current