Dapsone

Product NDC: 42291-008
11-digit product format: 422910008
Labeler code: 42291
Product ID: 42291-008_484819b5-cdfe-b9fe-e063-6394a90a1880
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dapsone
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA086841
Marketing category: ANDA
Marketing start: 2024-03-06
Substance: DAPSONE
Active strength: 25 mg/1
Pharmacologic classes: Sulfone [EPC], Sulfones [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A086841-001	DAPSONE	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A086841-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086841-001	DAPSONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086841-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086841-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086841-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086841-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086841-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086841-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086841-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086841-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086841-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086841-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086841-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086841-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086841-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086841-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086841-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086841-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086841-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086841-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086841-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086841-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086841-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086841-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086841-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086841-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086841-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086841-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086841-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086841-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086841-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086841-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086841-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086841-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086841-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086841-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086841-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086841-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086841-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086841-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086841-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086841-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dapsone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPSONE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8W5C518302	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197558	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
13002250-b4c5-5890-e063-6394a90a2036	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ae3f83f-9ccb-db71-5718-0b1e959868df	Product name	5	20260113
5ae2790a-f798-4a69-8811-64a4723c389a	Product name	5	20250325
b8929bfc-0002-d39a-046d-72ddf714efbe	Product name	6	20190618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-008-01	Dapsone	100 in 1 BOTTLE	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-008-01	EA - Each	42291-008	123f4210-2847-435f-a811-3c2cd57f823a	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-008	DAPSONE TABLET [AVKARE]	2	Current NDC, 1 package rows	20240802_13002250-b4c5-5890-e063-6394a90a2036.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dapsone	DAPSONE	AvKARE	13002250-b4c5-5890-e063-6394a90a2036	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086841 application number: ANDA086841 ndc (product): 42291-008
Dapsone	DAPSONE	AvKARE	459c00e0-2124-8965-e063-6294a90a4278	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086841 application number: ANDA086841
Dapsone	DAPSONE	Westminster Pharmaceuticals, LLC	7d317576-5edd-4c27-a00d-68b5944c04a8	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086841 application number: ANDA086841
Dapsone	DAPSONE	Westminster Pharmaceuticals, LLC	d3fc4934-d48b-4a29-9022-0c82bbdad399	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086841 application number: ANDA086841
Dapsone 100 mg	DAPSONE TABLETS	Everest Life Sciences. LLC	1d026bb6-05da-e9cf-e063-6394a90a2485	2024-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086841 application number: ANDA086841
Dapsone	DAPSONE	Proficient Rx LP	9cfe5fe7-abc7-4f48-a597-1b1a5c70a354	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086841 application number: ANDA086841

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8W5C518302	DAPSONE	80-08-0	DAPSONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197558	dapsone 25 MG Oral Tablet	PSN	13002250-b4c5-5890-e063-6394a90a2036	3
197558	dapsone 25 MG Oral Tablet	SCD	13002250-b4c5-5890-e063-6394a90a2036	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-008-01	42291000801	100 TABLET in 1 BOTTLE (42291-008-01)	100 tablet	2024-03-06	No	No	Current