Home NDC 46708-549 ADAPALENE
Product NDC 46708-549
11-digit product format 467080549
Labeler code 46708
Product ID 46708-549_2601af7f-4657-41f1-9b14-0efda19c971b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ADAPALENE
Dosage form GEL
Route TOPICAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA213508
Marketing category ANDA
Marketing start 2025-03-26
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 A213508-001 ADAPALENE ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213508-001 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 2026-08-18 06:07:40 2026-07 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213508-001 ADAPALENE 0.3% GEL / TOPICAL AB 2020-06-18 a50c72e98297…
Observed Orange Book normalized TE history# 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-549 ADAPALENE GEL [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 6 package rows 20250327_5dd6d825-f7c4-4a86-82cc-fcbb41df8542.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 46708-549-15 46708054915 1 TUBE in 1 CARTON (46708-549-15) / 15 g in 1 TUBE 1 tube 2025-03-26 No No Current 46708-549-45 46708054945 1 TUBE in 1 CARTON (46708-549-45) / 45 g in 1 TUBE 1 tube 2025-03-26 No No Current 46708-549-46 46708054946 1 BOTTLE, PUMP in 1 CARTON (46708-549-46) / 45 g in 1 BOTTLE, PUMP 2025-03-26 No No Current