Home NDC 50222-303 FINACEA FOAM
Product NDC 50222-303
11-digit product format 502220303
Labeler code 50222
Product ID 50222-303_f51a0452-513f-488f-b0f9-b723cf96bdf7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azelaic acid
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler LEO Pharma Inc.
Application NDA207071
Marketing category NDA
Marketing start 2018-10-01
Substance AZELAIC ACID
Active strength .15 g/g
Pharmacologic classes Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
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 N207071-001 FINACEA AZELAIC ACID 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207071-001 7700076 2027-09-18 Drug product 2015-08-26 N207071-001 10117812 2027-10-18 U-1796 Drug product 2018-11-15 N207071-001 9265725 2027-12-08 Drug product 2016-03-23 N207071-001 9211259 2029-02-28 U-1796 2016-01-14
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 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL RLD, RS 2015-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207071-001 FINACEA 15% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-07-29 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 7 · 279 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N207071-001 7700076 2027-09-18 Drug product 2015-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207071-001 10117812 2027-10-18 U-1796 Drug product 2018-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207071-001 9265725 2027-12-08 Drug product 2016-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207071-001 9211259 2029-02-28 U-1796 2016-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207071-001 7700076 2027-09-18 Drug product 2015-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207071-001 10117812 2027-10-18 U-1796 Drug product 2018-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207071-001 9265725 2027-12-08 Drug product 2016-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207071-001 9211259 2029-02-28 U-1796 2016-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207071-001 7700076 2027-09-18 Drug product 2015-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207071-001 10117812 2027-10-18 U-1796 Drug product 2018-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207071-001 9265725 2027-12-08 Drug product 2016-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207071-001 9211259 2029-02-28 U-1796 2016-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207071-001 7700076 2027-09-18 Drug product 2015-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207071-001 10117812 2027-10-18 U-1796 Drug product 2018-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207071-001 9265725 2027-12-08 Drug product 2016-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207071-001 9211259 2029-02-28 U-1796 2016-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207071-001 7700076 2027-09-18 Drug product 2015-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207071-001 10117812 2027-10-18 U-1796 Drug product 2018-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207071-001 9265725 2027-12-08 Drug product 2016-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207071-001 9211259 2029-02-28 U-1796 2016-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207071-001 7700076 2027-09-18 Drug product 2015-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207071-001 10117812 2027-10-18 U-1796 Drug product 2018-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207071-001 9265725 2027-12-08 Drug product 2016-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207071-001 9211259 2029-02-28 U-1796 2016-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207071-001 8435498 2024-03-01 U-1727 2015-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207071-001 7700076 2027-09-18 Drug product 2015-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207071-001 10117812 2027-10-18 U-1796 Drug product 2018-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207071-001 9265725 2027-12-08 Drug product 2016-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207071-001 9211259 2029-02-28 U-1796 2016-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207071-001 8435498 2024-03-01 U-1727 2015-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207071-001 7700076 2027-09-18 Drug product 2015-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207071-001 10117812 2027-10-18 U-1796 Drug product 2018-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207071-001 9265725 2027-12-08 Drug product 2016-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207071-001 9211259 2029-02-28 U-1796 2016-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207071-001 8435498 2024-03-01 U-1727 2015-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207071-001 7700076 2027-09-18 Drug product 2015-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207071-001 10117812 2027-10-18 U-1796 Drug product 2018-11-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207071-001 9265725 2027-12-08 Drug product 2016-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207071-001 9211259 2029-02-28 U-1796 2016-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207071-001 8435498 2024-03-01 U-1727 2015-08-26 d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base FINACEA FOAM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZELAIC ACID .15 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F2VW3D43YT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1659800 Internal RxNorm lookup 1659803 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 50222-303-50 FINACEA FOAM 50 g in 1 CAN AEROSOL, FOAM 50 3 50222-303-50 FINACEA FOAM 1 in 1 CARTON AEROSOL, FOAM 1 3 50222-303-91 FINACEA FOAM 1 in 1 CARTON AEROSOL, FOAM 1 3 50222-303-91 FINACEA FOAM 15 g in 1 CAN AEROSOL, FOAM 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50222-303 FINACEA FOAM (AZELAIC ACID) AEROSOL, FOAM [LEO PHARMA INC.] 3 Current NDC, Legacy NDC, 4 package rows 20201218_9fabd24e-4c3b-49a0-aa5f-c8d75ae67572.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 50222-303-50 50222030350 1 CAN in 1 CARTON (50222-303-50) / 50 g in 1 CAN 1 can 2018-10-01 0000-00-00 No No Current 50222-303-91 50222030391 1 CAN in 1 CARTON (50222-303-91) / 15 g in 1 CAN 1 can 2018-10-01 0000-00-00 Yes No Current