Home NDC 50222-505 Finacea
Product NDC 50222-505
11-digit product format 502220505
Labeler code 50222
Product ID 50222-505_be4ce27a-2c6d-4d04-880f-d18cf79b685e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azelaic acid
Dosage form GEL
Route TOPICAL
Labeler LEO Pharma Inc.
Application NDA021470
Marketing category NDA
Marketing start 2002-12-24
Marketing end 0000-00-00
Substance AZELAIC ACID
Active strength 0 g/g
Pharmacologic classes Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 N021470-001 FINACEA AZELAIC ACID 15% GEL / TOPICAL AB RLD, RS 2002-12-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021470-001 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 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50222-505 FINACEA (AZELAIC ACID) GEL [LEO PHARMA INC.] 11 Legacy NDC 20240126_bea1957c-55ca-48cd-8cbc-ed44d546a857.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50222-505-50 50222050550 1 TUBE in 1 CARTON (50222-505-50) > 50 g in 1 TUBE 1 tube 2018-10-01 0000-00-00 No No Current 50222-505-91 50222050591 1 TUBE in 1 CARTON (50222-505-91) > 3 g in 1 TUBE 1 tube 2018-10-01 0000-00-00 No No Current