Dapsone

Product NDC: 49938-101
11-digit product format: 499380101
Labeler code: 49938
Product ID: 49938-101_aef3166f-2850-4709-a00f-4c8e784d8022
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dapsone
Dosage form: TABLET
Route: ORAL
Labeler: Jacobus Pharmaceutical Company, Inc.
Application: ANDA086842
Marketing category: ANDA
Marketing start: 2008-08-15
Marketing end: 2025-08-31
Substance: DAPSONE
Active strength: 100 mg/1
Pharmacologic classes: Sulfone [EPC], Sulfones [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49938-101		D	Discontinued by firm	2026-08-03
excluded product	product	49938-101		D	Discontinued by firm	2026-08-03
excluded package	package	49938-101	49938-101-01	D	Discontinued by firm	2026-08-03
excluded package	package	49938-101	49938-101-28	D	Discontinued by firm	2026-08-03
excluded package	package	49938-101	49938-101-30	D	Discontinued by firm	2026-08-03

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 · 28 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49938-101-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49938-101-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49938-101-01	`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	49938-101-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49938-101-01	`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	49938-101-01	`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	49938-101-01	`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	49938-101-01	`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	49938-101-01	`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	49938-101-01	`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	49938-101-01	`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	49938-101-01	`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	49938-101-01	`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	49938-101-01	`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	49938-101-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A086842-001	DAPSONE	DAPSONE	100MG	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
A086842-001	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	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086842-001	DAPSONE	100MG	TABLET / ORAL	AB	RLD, RS, 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	A086842-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086842-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086842-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086842-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086842-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086842-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086842-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086842-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086842-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086842-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086842-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086842-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086842-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086842-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086842-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086842-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086842-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086842-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086842-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086842-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086842-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086842-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086842-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086842-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086842-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086842-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086842-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086842-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086842-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086842-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086842-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086842-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086842-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086842-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086842-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086842-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086842-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086842-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086842-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086842-001	AB	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49938-101-01	EA - Each	49938-101	517185e5-4993-405d-8a30-feec14f6d547	1	2016-03-04
49938-101-30	EA - Each	49938-101	fc6e15f1-31e3-4a53-9c99-5072e0e6834a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DAPSONE	ACTIVE INGREDIENT	8W5C518302	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	4
DAPSONE	ACTIVE MOIETY	8W5C518302	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	4
DAPSONE	ACTIVE INGREDIENT	8W5C518302	DAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
DAPSONE	ACTIVE MOIETY	8W5C518302	DAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DAPSONE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
Dapsone	ACTIVE INGREDIENT	8W5C518302	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	1
Dapsone	ACTIVE MOIETY	8W5C518302	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	1
Colloidal Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49938-101	DAPSONE TABLET [JACOBUS PHARMACEUTICAL COMPANY, INC.]	6	Legacy NDC	20221220_0792169d-c6f9-4af0-93ae-b75d710c47a9.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dapsone	DAPSONE	Westminster Pharmaceuticals, LLC	7d317576-5edd-4c27-a00d-68b5944c04a8	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086842 application number: ANDA086842
Dapsone	DAPSONE	Westminster Pharmaceuticals, LLC	d3fc4934-d48b-4a29-9022-0c82bbdad399	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086842 application number: ANDA086842
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): 086842 application number: ANDA086842
Dapsone	DAPSONE	Proficient Rx LP	9cfe5fe7-abc7-4f48-a597-1b1a5c70a354	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086842 application number: ANDA086842

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	2b87248b-66df-70ac-e054-00144ff8d46c	2
197557	dapsone 100 MG Oral Tablet	PSN	d97e6985-b508-43c0-8c1f-6dfe9cc8a528	2
197558	dapsone 25 MG Oral Tablet	PSN	2b87248b-66df-70ac-e054-00144ff8d46c	2
197558	dapsone 25 MG Oral Tablet	PSN	d97e6985-b508-43c0-8c1f-6dfe9cc8a528	2
197557	dapsone 100 MG Oral Tablet	SCD	2b87248b-66df-70ac-e054-00144ff8d46c	2
197557	dapsone 100 MG Oral Tablet	SCD	d97e6985-b508-43c0-8c1f-6dfe9cc8a528	2
197558	dapsone 25 MG Oral Tablet	SCD	2b87248b-66df-70ac-e054-00144ff8d46c	2
197558	dapsone 25 MG Oral Tablet	SCD	d97e6985-b508-43c0-8c1f-6dfe9cc8a528	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49938-101-01	49938010101	100 TABLET in 1 BOTTLE (49938-101-01)	100 tablet	2016-02-08	2023-11-30	No	No	Current
49938-101-28	49938010128	2 BLISTER PACK in 1 CARTON (49938-101-28) > 14 TABLET in 1 BLISTER PACK	2 blister pack	2008-08-15	0000-00-00	No	No	Current
49938-101-30	49938010130	2 BLISTER PACK in 1 CARTON (49938-101-30) > 15 TABLET in 1 BLISTER PACK	2 blister pack	2008-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DAPSONE Tablets, USP 25 mg & 100 mg	Jacobus Pharmaceutical Company, Inc.	2022-12-16	HUMAN PRESCRIPTION DRUG LABEL	6
DAPSONE Tablets, USP 25 mg & 100 mg	Jacobus Pharmaceutical Company, Inc. \| Jacobus Pharmacueitcal Company, Inc.	2022-12-16	HUMAN PRESCRIPTION DRUG LABEL	4
DAPSONE Tablets, USP 25 mg & 100 mg	Department of State Health Services, Pharmacy Branch	2016-03-11	HUMAN PRESCRIPTION DRUG LABEL	2
DAPSONE Tablets, USP 25 mg & 100 mg	Physicians Total Care, Inc.	2010-06-15	HUMAN PRESCRIPTION DRUG LABEL	2