Dapsone

Product NDC: 29033-037
Requested package NDC: 29033-037-30
11-digit product format: 290330037
Labeler code: 29033
Product ID: 29033-037_0e4dae40-fd8b-473f-86fd-dfa14c68455b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dapsone
Dosage form: TABLET
Route: ORAL
Labeler: Nostrum Laboratories, Inc.
Application: ANDA203887
Marketing category: ANDA
Marketing start: 2016-05-09
Marketing end: 0000-00-00
Substance: DAPSONE
Active strength: 100 mg/1
Pharmacologic classes: Sulfone [EPC],Sulfones [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	29033-037	29033-037-30	I	Inactivated by FDA		2026-08-11

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203887-001	DAPSONE	DAPSONE	25MG	TABLET / ORAL	AB		2016-05-06
A203887-002	DAPSONE	DAPSONE	100MG	TABLET / ORAL	AB		2016-05-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203887-001	AB
A203887-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203887-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-05-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203887-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-05-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A203887-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203887-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203887-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203887-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203887-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203887-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203887-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203887-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203887-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203887-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203887-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203887-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203887-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203887-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203887-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203887-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203887-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203887-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203887-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203887-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203887-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203887-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203887-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203887-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203887-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203887-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203887-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203887-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203887-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203887-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203887-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203887-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203887-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203887-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203887-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203887-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203887-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203887-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203887-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203887-002	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
29033-037-30	2026-01-29	C162847	48780-1	49896155-a4aa-586f-e063-e6dba90add90	DAPSONE Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29033-037-30	Dapsone	30 in 1 BOTTLE	TABLET	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29033-037-30	EA - Each	29033-037	0ac0b7e6-e9ca-4a48-a511-6d0689c845e4	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29033-037	DAPSONE TABLET [NOSTRUM LABORATORIES, INC.]	5	Legacy NDC, 1 package rows	20230121_3fa58b58-f588-4a0e-9e49-0f687bc294c9.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
Dapsone 25mg	DAPSONE 25MG	Solis Pharmaceuticals Inc.	50204029-4c29-5b8d-e063-6394a90af383	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203887 application number: ANDA203887
Dapsone	DAPSONE	Golden State Medical Supply, Inc.	69248ad0-6998-42a2-88a9-fa682e5ea5ee	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203887 application number: ANDA203887

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
197557	dapsone 100 MG Oral Tablet	PSN	69248ad0-6998-42a2-88a9-fa682e5ea5ee	6
197558	dapsone 25 MG Oral Tablet	PSN	69248ad0-6998-42a2-88a9-fa682e5ea5ee	6
197557	dapsone 100 MG Oral Tablet	SCD	69248ad0-6998-42a2-88a9-fa682e5ea5ee	6
197558	dapsone 25 MG Oral Tablet	SCD	69248ad0-6998-42a2-88a9-fa682e5ea5ee	6
197557	dapsone 100 MG Oral Tablet	PSN	3fa58b58-f588-4a0e-9e49-0f687bc294c9	5
197558	dapsone 25 MG Oral Tablet	PSN	3fa58b58-f588-4a0e-9e49-0f687bc294c9	5
197557	dapsone 100 MG Oral Tablet	SCD	3fa58b58-f588-4a0e-9e49-0f687bc294c9	5
197558	dapsone 25 MG Oral Tablet	SCD	3fa58b58-f588-4a0e-9e49-0f687bc294c9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29033-037-30	29033003730	30 TABLET in 1 BOTTLE (29033-037-30)	30 tablet	2016-05-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DAPSONE Tablets, USP Rx Only	Golden State Medical Supply, Inc.	2024-12-06	HUMAN PRESCRIPTION DRUG LABEL	6
DAPSONE Tablets, USP Rx Only	Nostrum Laboratories, Inc.	2023-01-20	HUMAN PRESCRIPTION DRUG LABEL	5