Home NDC 50419-825 Finacea
Product NDC 50419-825
11-digit product format 504190825
Labeler code 50419
Product ID 50419-825_b6b1dc01-47b9-45f5-b659-3a2c2d83eecd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azelaic acid
Dosage form GEL
Route TOPICAL
Labeler Bayer HealthCare Pharmaceuticals 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 2020-12-31
Current FDA listing Historical FDA.report record 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 2 · 80 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021470-001 FINACEA 15% GEL / TOPICAL AB RLD, RS 2002-12-24 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 N021470-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021470-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021470-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021470-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50419-825-01 2023-01-30 These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995 50419-825-02 2023-01-30 These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995 50419-825-03 2023-01-30 These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995 50419-825-74 2023-01-30 These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995 50419-825-01 2021-01-29 These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995 50419-825-02 2021-01-29 These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995 50419-825-03 2021-01-29 These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995 50419-825-74 2021-01-29 These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995
DailyMed Socrata Ingredients# 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#