Home NDC 59651-604 Adapalene and benzoyl peroxide
Product NDC 59651-604
11-digit product format 596510604
Labeler code 59651
Product ID 59651-604_25e4ee12-f43a-4c87-9e34-64e91d06a368
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adapalene and benzoyl peroxide
Dosage form GEL
Route TOPICAL
Labeler Aurobindo Pharma Limited
Application ANDA217384
Marketing category ANDA
Marketing start 2026-07-22
Substance ADAPALENE; BENZOYL PEROXIDE
Active strength 3; 25 mg/g; 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 43 .
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 A217384-001 ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.3%;2.5% GEL / TOPICAL AB 2026-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217384-001 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.
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 2026-09-14 22:38:34 2026-08 A217384-001 ADAPALENE AND BENZOYL PEROXIDE 0.3%;2.5% GEL / TOPICAL AB 2026-07-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217384-001 ADAPALENE AND BENZOYL PEROXIDE 0.3%;2.5% GEL / TOPICAL AB 2026-07-22 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A217384-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217384-001 AB 1 caaa826d4ba7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Adapalene and benzoyl peroxide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ADAPALENE 3 mg/g BENZOYL PEROXIDE 25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1L4806J2QF Internal UNII lookup W9WZN9A0GM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1663745 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-604-46 59651060446 1 BOTTLE, PUMP in 1 CARTON (59651-604-46) / 45 g in 1 BOTTLE, PUMP 2026-07-22 No No Current 59651-604-60 59651060460 1 BOTTLE, PUMP in 1 CARTON (59651-604-60) / 60 g in 1 BOTTLE, PUMP 2026-07-22 No No Current