Finacea

Product NDC: 50090-3032
11-digit product format: 500903032
Labeler code: 50090
Product ID: 50090-3032_0e2fadc5-3a2e-4027-93ba-eff9990cfc65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azelaic acid
Dosage form: GEL
Route: TOPICAL
Labeler: A-S Medication Solutions
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-3032		I	Inactivated by FDA		2026-08-17
excluded package	package	50090-3032	50090-3032-0	I	Inactivated by FDA		2026-08-17

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 · 30 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3032-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3032-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3032-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3032-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3032-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3032-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3032-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3032-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3032-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3032-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3032-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-3032-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-3032-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-3032-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-3032-0	`1332a3947898…`	`d4bfe170f9cd…`

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021470-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021470-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021470-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021470-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021470-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021470-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021470-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021470-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021470-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021470-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021470-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021470-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021470-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021470-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021470-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021470-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021470-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021470-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021470-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021470-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021470-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021470-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021470-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021470-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021470-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021470-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021470-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021470-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021470-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021470-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021470-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021470-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021470-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021470-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021470-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021470-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021470-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021470-001	AB	1	`3a93d1ddd44b…`
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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
6c6fc281-9445-2e9e-1c29-a09ddbc4299c	Product name	2	20200213
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
2a856070-cbe7-4f85-be0f-09885ff91196	Product name	1	20150806

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3032-0	2023-01-30	C162847	48780-1	f386c64a-3729-0266-e053-dadaa90a7c1a	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3032-0	Finacea	50 g in 1 TUBE	GEL	50		3
50090-3032-0	Finacea	1 in 1 CARTON	GEL	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3032-0	GM - Gram	50090-3032	af449811-a084-48d7-874e-1ea4f17bb356	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3032	FINACEA (AZELAIC ACID) GEL [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 2 package rows	20200121_9f40cd45-58a6-4376-9220-84bfe7d7e358.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azelaic Acid Gel	AZELAIC ACID	Sandoz Inc.	66178511-5c1a-4ecd-bc98-2ceb54e710ac	2021-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021470 application number: NDA021470

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F2VW3D43YT	AZELAIC ACID	123-99-9	AZELAIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1041518	azelaic acid 15 % Topical Gel	PSN	9f40cd45-58a6-4376-9220-84bfe7d7e358	3
1043748	Finacea 15 % Topical Gel	PSN	9f40cd45-58a6-4376-9220-84bfe7d7e358	3
1043748	azelaic acid 0.15 MG/MG Topical Gel [Finacea]	SBD	9f40cd45-58a6-4376-9220-84bfe7d7e358	3
1041518	azelaic acid 0.15 MG/MG Topical Gel	SCD	9f40cd45-58a6-4376-9220-84bfe7d7e358	3
1041518	azelaic acid 15 % Topical Gel	SY	9f40cd45-58a6-4376-9220-84bfe7d7e358	3
1043748	Finacea 0.15 MG/MG Topical Gel	SY	9f40cd45-58a6-4376-9220-84bfe7d7e358	3
1043748	Finacea 15 % Topical Gel	SY	9f40cd45-58a6-4376-9220-84bfe7d7e358	3
1043748	Finacea Plus (azelaic acid 0.15 MG/MG) Topical Gel	SY	9f40cd45-58a6-4376-9220-84bfe7d7e358	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3032-0	50090303200	1 TUBE in 1 CARTON (50090-3032-0) > 50 g in 1 TUBE	1 tube	2017-06-01	0000-00-00	No	No	Current