Home NDC 0781-7182 Adapalene and Benzoyl Peroxide
Product NDC 0781-7182
11-digit product format 007817182
Labeler code 0781
Product ID 0781-7182_12b7a31c-65a0-46d4-a655-3015c95b6386
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adapalene and Benzoyl Peroxide
Dosage form GEL
Route TOPICAL
Labeler Sandoz Inc.
Application ANDA206164
Marketing category ANDA
Marketing start 2018-05-23
Marketing end 0000-00-00
Substance ADAPALENE; BENZOYL PEROXIDE
Active strength 1 mg/g; mg/g
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 A206164-001 ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206164-001 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 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL AB 2018-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206164-001 ADAPALENE AND BENZOYL PEROXIDE 0.1%;2.5% GEL / TOPICAL 2018-05-23 cb3db0bc1861…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-7182-19 00781718219 1 TUBE in 1 CARTON (0781-7182-19) > 45 g in 1 TUBE 1 tube 2018-05-23 0000-00-00 No No Current 0781-7182-70 00781718270 1 BOTTLE, PUMP in 1 CARTON (0781-7182-70) > 45 g in 1 BOTTLE, PUMP 2018-05-23 0000-00-00 No No Current