RIDAURA

Product NDC: 65483-093
11-digit product format: 654830093
Labeler code: 65483
Product ID: 65483-093_6008addc-7f8e-45bb-8aec-54dd54a788ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: auranofin
Dosage form: CAPSULE
Route: ORAL
Labeler: Prometheus Laboratories Inc.
Application: NDA018689
Marketing category: NDA
Marketing start: 1985-04-24
Marketing end: 0000-00-00
Substance: AURANOFIN
Active strength: 3 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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	65483-093		I	Inactivated by FDA		2026-08-11
excluded package	package	65483-093	65483-093-06	I	Inactivated by FDA		2026-08-11

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 · 44 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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`1332a3947898…`	`d4bfe170f9cd…`
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	65483-093-06	`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	65483-093-06	`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	65483-093-06	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65483-093-06	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65483-093-06	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65483-093-06	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65483-093-06	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N018689-001	RIDAURA	AURANOFIN	3MG	CAPSULE / ORAL		RLD, RS	1985-05-24

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018689-001	RIDAURA	3MG	CAPSULE / ORAL	RLD, RS	1985-05-24	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
ee8d39e4-f907-4d8f-130c-6fceb48ba86a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65483-093-06	2019-11-13	C162847	48780-1	97449f38-be91-f6ea-e053-dbdaa90aa703	PRESCRIBING INFORMATION RIDAURA ® Auranofin Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65483-093-06	RIDAURA	60 in 1 BOTTLE	CAPSULE	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65483-093-06	EA - Each	65483-093	bd6f6a6e-f653-4035-9315-e68e5a2584b3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
auranofin	ACTIVE INGREDIENT	3H04W2810V	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
auranofin	ACTIVE MOIETY	3H04W2810V	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
cetylpyridinium chloride	INACTIVE INGREDIENT	D9OM4SK49P	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
D&C Red No. 33	INACTIVE INGREDIENT	9DBA0SBB0L	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
lactose	INACTIVE INGREDIENT	J2B2A4N98G	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
povidone	INACTIVE INGREDIENT	FZ989GH94E	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65483-093	RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]	3	Legacy NDC, 1 package rows	20111215_05c34ddf-a0f7-4267-83f5-d02be3defc37.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RIDAURA	AURANOFIN	Sebela Pharmaceuticals Inc.	43ba3de1-ab2e-06f6-e054-00144ff8d46c	2025-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018689 application number: NDA018689
Auranofin	AURANOFIN	Coral Way Pharma, LLC	d688978b-8b91-4377-9f1d-89b805f5747c	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018689 application number: NDA018689

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3H04W2810V	AURANOFIN	34031-32-8	AURANOFIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197386	auranofin 3 MG Oral Capsule	PSN	05c34ddf-a0f7-4267-83f5-d02be3defc37	3
213510	Ridaura 3 MG Oral Capsule	PSN	05c34ddf-a0f7-4267-83f5-d02be3defc37	3
213510	auranofin 3 MG Oral Capsule [Ridaura]	SBD	05c34ddf-a0f7-4267-83f5-d02be3defc37	3
197386	auranofin 3 MG Oral Capsule	SCD	05c34ddf-a0f7-4267-83f5-d02be3defc37	3
213510	Ridaura 3 MG Oral Capsule	SY	05c34ddf-a0f7-4267-83f5-d02be3defc37	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
65483-093-06	65483009306	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRESCRIBING INFORMATION RIDAURA ® Auranofin Capsules	Prometheus Laboratories Inc. \| Patheon, Inc., Toronto Region Operations \| Patheon, Inc., Burlington Century Operations	2011-12-15	HUMAN PRESCRIPTION DRUG LABEL	3