Sulfamethoxazole and Trimethoprim

Product NDC: 10544-092
11-digit product format: 105440092
Labeler code: 10544
Product ID: 10544-092_57ab565c-87af-4732-a757-09ae9f42cd7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA090828
Marketing category: ANDA
Marketing start: 2012-12-05
Marketing end: 0000-00-00
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 800 mg/1; mg/1
Pharmacologic classes: Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	10544-092		I	Inactivated by FDA	2026-09-09
excluded package	package	10544-092	10544-092-06	I	Inactivated by FDA	2026-09-09
excluded package	package	10544-092	10544-092-14	I	Inactivated by FDA	2026-09-09

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 · 66 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	10544-092-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-092-14	`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	10544-092-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-092-14	`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	10544-092-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-092-14	`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	10544-092-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-092-14	`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	10544-092-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-092-14	`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	10544-092-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-092-14	`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	10544-092-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-092-14	`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	10544-092-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-092-14	`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	10544-092-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-092-14	`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	10544-092-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-092-14	`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	10544-092-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-092-14	`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	10544-092-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-092-14	`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	10544-092-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-092-14	`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	10544-092-06	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-092-14	`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	10544-092-06	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-092-14	`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	10544-092-06	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-092-14	`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	10544-092-06	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-092-14	`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	10544-092-06	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-092-14	`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	10544-092-06	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-092-14	`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	10544-092-06	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-092-14	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB		2010-12-22
A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB		2010-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090828-001	AB
A090828-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090828-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090828-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-12-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090828-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090828-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090828-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090828-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090828-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090828-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090828-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090828-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090828-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090828-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090828-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090828-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090828-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090828-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090828-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090828-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090828-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090828-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090828-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090828-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090828-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090828-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090828-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090828-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090828-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090828-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090828-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090828-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090828-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090828-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090828-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090828-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090828-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090828-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090828-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090828-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090828-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090828-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090828-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090828-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ce811b5-329e-27f8-b5ff-66d52b435c00	Product name	3	20240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27	Product name	3	20221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fad	Product name	3	20190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-092-06	2019-11-27	C162847	48780-1	9855d018-dfe5-cd31-e053-dbdaa90ab51a	Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (Double Strength) and 400 mg/80 mg
10544-092-14	2019-11-27	C162847	48780-1	9855d018-dfe5-cd31-e053-dbdaa90ab51a	Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (Double Strength) and 400 mg/80 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-092-06	Sulfamethoxazole and Trimethoprim	6 in 1 BOTTLE	TABLET	6		3
10544-092-14	Sulfamethoxazole and Trimethoprim	14 in 1 BOTTLE	TABLET	14		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-092	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	3	Legacy NDC, 2 package rows	20130523_cd6dced7-379a-4a3a-9267-8b88bfa8cfe3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JE42381TNV	SULFAMETHOXAZOLE	723-46-6	SULFAMETHOXAZOLE
AN164J8Y0X	TRIMETHOPRIM	738-70-5	TRIMETHOPRIM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	cd6dced7-379a-4a3a-9267-8b88bfa8cfe3	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	cd6dced7-379a-4a3a-9267-8b88bfa8cfe3	3
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	cd6dced7-379a-4a3a-9267-8b88bfa8cfe3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-092-06	10544009206	6 in 1 BOTTLE	Historical
10544-092-14	10544009214	14 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (Double Strength) and 400 mg/80 mg	Blenheim Pharmacal, Inc.	2013-05-23	HUMAN PRESCRIPTION DRUG LABEL	3