DAPSONE

Product NDC: 10135-655
11-digit product format: 101350655
Labeler code: 10135
Product ID: 10135-655_afbef0ba-7481-405d-9219-62ec25d9a618
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dapsone
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA206505
Marketing category: ANDA
Marketing start: 2018-05-01
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: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10135-655		I	Inactivated by FDA	2026-08-10
excluded package	package	10135-655	10135-655-01	I	Inactivated by FDA	2026-08-10
excluded package	package	10135-655	10135-655-30	I	Inactivated by FDA	2026-08-10

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 2 · 63 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	10135-655-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-655-01	`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	10135-655-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-655-01	`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	10135-655-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-655-01	`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	10135-655-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-655-01	`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	10135-655-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-655-01	`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	10135-655-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-655-01	`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	10135-655-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-655-01	`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	10135-655-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-655-01	`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	10135-655-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-655-01	`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	10135-655-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-655-01	`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	10135-655-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-655-01	`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	10135-655-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-655-01	`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	10135-655-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-655-01	`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	10135-655-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-655-01	`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	10135-655-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-655-01	`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	10135-655-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10135-655-01	`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	10135-655-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10135-655-01	`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	10135-655-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10135-655-01	`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	10135-655-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10135-655-01	`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	10135-655-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10135-655-01	`e2bbac7714bc…`	`27bdfed8d636…`

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
A206505-001	DAPSONE	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01
A206505-002	DAPSONE	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206505-001	AB
A206505-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB	RS	2016-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB		2016-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB		2016-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB		2016-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB		2016-12-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB		2016-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206505-001	DAPSONE	25MG	TABLET / ORAL	AB		2016-12-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206505-002	DAPSONE	100MG	TABLET / ORAL	AB		2016-12-01	`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	A206505-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206505-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206505-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206505-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206505-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206505-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206505-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206505-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206505-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206505-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206505-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206505-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206505-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206505-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206505-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206505-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206505-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206505-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206505-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206505-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206505-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206505-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206505-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206505-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206505-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206505-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206505-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206505-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206505-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206505-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206505-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206505-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206505-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206505-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206505-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206505-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206505-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206505-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206505-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206505-002	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
10135-655-01	2020-01-31	C162847	48780-1	9d75b9d1-01b0-f424-e053-dadaa90a57ce	Dapsone
10135-655-30	2020-01-31	C162847	48780-1	9d75b9d1-01b0-f424-e053-dadaa90a57ce	Dapsone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-655-01	DAPSONE	100 in 1 BOTTLE	TABLET	100		1
10135-655-30	DAPSONE	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-655-01	EA - Each	10135-655	3d27708b-088d-4885-a56a-0f5169fd5c78	1	2018-07-03
10135-655-30	EA - Each	10135-655	0f323d77-6800-401f-871e-78e913da1198	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-655	DAPSONE TABLET [MARLEX PHARMACEUTICALS INC]	1	Legacy NDC, 2 package rows	20180501_6c2159ce-5ef2-418c-bb14-e58f55438f80.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DAPSONE	DAPSONE	ANI Pharmaceuticals, Inc.	57a47368-d1f6-4d61-a2ee-c5f1fe7ff690	2025-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206505 application number: ANDA206505

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	6c2159ce-5ef2-418c-bb14-e58f55438f80	1
197558	dapsone 25 MG Oral Tablet	PSN	6c2159ce-5ef2-418c-bb14-e58f55438f80	1
197557	dapsone 100 MG Oral Tablet	SCD	6c2159ce-5ef2-418c-bb14-e58f55438f80	1
197558	dapsone 25 MG Oral Tablet	SCD	6c2159ce-5ef2-418c-bb14-e58f55438f80	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-655-01	10135065501	100 in 1 BOTTLE	Historical
10135-655-30	10135065530	30 in 1 BOTTLE	Historical