Home NDC 49908-118 Adapalene
Product NDC 49908-118
11-digit product format 499080118
Labeler code 49908
Product ID 49908-118_2b371635-a5d6-4596-e063-6394a90a8ee6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adapalene
Dosage form SWAB
Route TOPICAL
Labeler CALL INC. (dba Rochester Pharmaceuticals)
Application ANDA204593
Marketing category ANDA
Marketing start 2019-02-04
Substance ADAPALENE
Active strength 1 mg/mL
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 49908-118-14 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 49908-118-14 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 49908-118-14 bd6a592717d7…303034d00443…
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 A204593-001 ADAPALENE ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204593-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204593-001 ADAPALENE 0.1% SOLUTION / TOPICAL AB 2016-01-05 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 mg/mL
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 798061 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49908-118-00 Adapalene 1.2 mL in 1 POUCH SWAB 1.2 7 49908-118-14 Adapalene 14 in 1 CARTON SWAB 14 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49908-118 ADAPALENE SWAB [CALL INC. (DBA ROCHESTER PHARMACEUTICALS)] 7 Current NDC, Legacy NDC, 2 package rows 20250110_5ce78048-0e5c-45b5-82bf-9f61307611cd.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 49908-118-00 49908011800 1.2 mL in 1 POUCH 1.2 ml Historical 49908-118-14 49908011814 14 POUCH in 1 CARTON (49908-118-14) / 1.2 mL in 1 POUCH (49908-118-00) 14 pouch 2019-02-04 0000-00-00 No No Current