RIDAURA

Product NDC: 54766-093
11-digit product format: 547660093
Labeler code: 54766
Product ID: 54766-093_431445cb-3625-82d8-e063-6394a90aeaea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: auranofin
Dosage form: CAPSULE
Route: ORAL
Labeler: Sebela Pharmaceuticals Inc.
Application: NDA018689
Marketing category: NDA
Marketing start: 2016-12-15
Marketing end: 2027-10-31
Substance: AURANOFIN
Active strength: 3 mg/1
NDC exclude flag: No
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: RIDAURA

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AURANOFIN	3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3H04W2810V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197386	Internal RxNorm lookup
213510	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
43ba3de1-ab2e-06f6-e054-00144ff8d46c	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54766-093-06	RIDAURA	60 in 1 BOTTLE	CAPSULE	60		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54766-093-06	EA - Each	54766-093	dc5f736a-c104-4a94-9a8c-9cb84ba3844e	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54766-093	RIDAURA (AURANOFIN) CAPSULE [SEBELA PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 1 package rows	20181215_43ba3de1-ab2e-06f6-e054-00144ff8d46c.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 ndc (product): 54766-093
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	43ba3de1-ab2e-06f6-e054-00144ff8d46c	5
213510	Ridaura 3 MG Oral Capsule	PSN	43ba3de1-ab2e-06f6-e054-00144ff8d46c	5
213510	auranofin 3 MG Oral Capsule [Ridaura]	SBD	43ba3de1-ab2e-06f6-e054-00144ff8d46c	5
197386	auranofin 3 MG Oral Capsule	SCD	43ba3de1-ab2e-06f6-e054-00144ff8d46c	5
213510	Ridaura 3 MG Oral Capsule	SY	43ba3de1-ab2e-06f6-e054-00144ff8d46c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54766-093-06	54766009306	60 CAPSULE in 1 BOTTLE (54766-093-06)	60 capsule	2016-12-15	2027-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRESCRIBING INFORMATION RIDAURA ® Auranofin Capsules	Sebela Pharmaceuticals Inc. \| Patheon, Inc.	2025-11-08	HUMAN PRESCRIPTION DRUG LABEL	5