Sulfamethoxazole and Trimethoprim

Product NDC: 65862-420
11-digit product format: 658620420
Labeler code: 65862
Product ID: 65862-420_e4ea8e99-58d4-4c1b-b84c-db0838610059
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090624
Marketing category: ANDA
Marketing start: 2010-02-16
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 800; 160 mg/1; mg/1
Pharmacologic classes: Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
unfinished product	product	65862-420		UNFINISHED	Active or certified unfinished drug listing	2026-10-05
unfinished package	package	65862-420	65862-420-12	UNFINISHED	Active or certified unfinished drug listing	2026-10-05
unfinished package	package	65862-420	65862-420-15	UNFINISHED	Active or certified unfinished drug listing	2026-10-05

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 · 55 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-420-12	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-420-15	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-420-12	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-420-15	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-420-12	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-420-15	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-420-12	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-420-15	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-420-12	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-420-15	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-420-12	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-420-15	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-420-12	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-420-15	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-420-12	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-420-15	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-420-12	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-420-15	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-420-12	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-420-15	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-420-12	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-420-15	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-420-12	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-420-15	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-420-12	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-420-15	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-420-12	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-420-15	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-420-12	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-420-15	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-420-15	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-420-15	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-420-15	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-420-15	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-420-15	`263afe128892…`	`91768de4ddbe…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB		2010-02-16
A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB		2010-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090624-001	AB
A090624-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090624-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090624-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090624-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090624-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090624-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090624-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090624-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090624-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090624-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090624-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090624-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090624-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090624-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090624-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090624-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090624-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090624-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090624-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090624-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090624-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090624-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090624-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090624-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090624-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090624-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090624-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090624-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090624-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090624-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090624-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090624-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090624-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090624-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090624-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090624-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090624-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090624-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090624-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090624-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090624-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Sulfamethoxazole and Trimethoprim
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULFAMETHOXAZOLE	800 mg/1
TRIMETHOPRIM	160 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
AN164J8Y0X	Internal UNII lookup
JE42381TNV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198334	Internal RxNorm lookup
198335	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
284b5dac-2b8d-46bf-95fe-80ce03fa178a	Available on FDA.report

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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fad	Product name	3	20190926
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-420-01	Sulfamethoxazole and Trimethoprim	100 in 1 BOTTLE	TABLET	100	17
65862-420-05	Sulfamethoxazole and Trimethoprim	500 in 1 BOTTLE	TABLET	500	17
65862-420-20	Sulfamethoxazole and Trimethoprim	20 in 1 BOTTLE	TABLET	20	17
65862-420-99	Sulfamethoxazole and Trimethoprim	1000 in 1 BOTTLE	TABLET	1000	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-420-01	EA - Each	65862-420	0441fe3e-5d24-45d9-ae2d-298fb09d776d	1	2012-07-24
65862-420-05	EA - Each	65862-420	0c7bac96-66bb-484f-8713-af5e0a075068	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]	8
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]	8
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]	8
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]	8
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]	8
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]	8
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CLINICAL SOLUTIONS WHOLESALE]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CLINICAL SOLUTIONS WHOLESALE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-420	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]	17	Current NDC, Legacy NDC, 4 package rows	20250317_284b5dac-2b8d-46bf-95fe-80ce03fa178a.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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Preferred Pharmaceuticals Inc.	d60c218c-6529-4944-af0b-a9dc720f32e9	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	ce44959b-4bfe-4ba9-9fc2-7f9d4663d542	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	ec2e335c-3357-40d8-9615-a09fc40ce5f4	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	c45ac3a4-d397-486e-abd1-349916543068	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Cardinal Health 107, LLC	08500fcb-dbec-4ac2-91c3-189d27907ec0	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Unit Dose Solutions, Inc.	562e2547-db2d-e2d2-e063-6294a90a1f5d	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	St. Mary's Medical Park Pharmacy	e3a49508-0ebe-1334-e053-2a95a90ae173	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Coupler LLC	518cc045-a12b-f08f-e063-6394a90acb0c	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	AvPAK	29df8839-3dfa-0b2b-c5a3-906db6997b3b	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	75b9d194-b960-4943-bedc-96e3d65c4da9	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	7f82e5e0-b627-a3f3-e053-2991aa0abaa5	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Sportpharm LLC	52304e5e-d097-48f2-8b64-210908e4eb54	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	99e1ace6-7665-4f87-82fd-5e7c4989e098	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfameth/Trimeth-DS	SULFAMETH/TRIMETH-DS	Direct_Rx	90026ce8-3305-6272-e053-2995a90a57e0	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	8c3e4738-0e0a-a854-e053-2995a90a7d71	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	f7f97520-d063-ec87-e053-6294a90aae0c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	471c5995-a4df-fbe3-e063-6394a90aa50e	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	QPharma, Inc.	41529314-b203-47f4-88dd-5aa57c74985f	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	VERITYRX, LLC	427b8040-99a4-8e81-e063-6394a90a76c5	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	1274cefb-0799-e2e4-e063-6394a90aad02	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624

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	3ef62512-0dc3-4821-9b60-6b375841c4c0	26
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	3ef62512-0dc3-4821-9b60-6b375841c4c0	26
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	3ef62512-0dc3-4821-9b60-6b375841c4c0	26
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	99e1ace6-7665-4f87-82fd-5e7c4989e098	21
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	62616708-a538-459f-9b7f-ed90c6aa5fc6	21
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	99e1ace6-7665-4f87-82fd-5e7c4989e098	21
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	62616708-a538-459f-9b7f-ed90c6aa5fc6	21
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	99e1ace6-7665-4f87-82fd-5e7c4989e098	21
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	62616708-a538-459f-9b7f-ed90c6aa5fc6	21
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	c4da9c4f-0704-4ed5-9d19-5c949f37f726	20
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	c4da9c4f-0704-4ed5-9d19-5c949f37f726	20
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	c4da9c4f-0704-4ed5-9d19-5c949f37f726	20
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	fd90d8bd-1b84-4347-a98a-f8f94746f3e4	19
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	fd90d8bd-1b84-4347-a98a-f8f94746f3e4	19
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	fd90d8bd-1b84-4347-a98a-f8f94746f3e4	19
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	284b5dac-2b8d-46bf-95fe-80ce03fa178a	17
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	284b5dac-2b8d-46bf-95fe-80ce03fa178a	17
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	d8239804-d234-491b-965d-89a7796a5e4d	17
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	284b5dac-2b8d-46bf-95fe-80ce03fa178a	17
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	284b5dac-2b8d-46bf-95fe-80ce03fa178a	17
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	d8239804-d234-491b-965d-89a7796a5e4d	17
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	284b5dac-2b8d-46bf-95fe-80ce03fa178a	17
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	284b5dac-2b8d-46bf-95fe-80ce03fa178a	17
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	d8239804-d234-491b-965d-89a7796a5e4d	17
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	14767ff8-7803-4922-ac03-ff80c061e5ba	16
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	c2307cc2-43ee-4319-ad58-d1d28a95e5aa	16
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	c2307cc2-43ee-4319-ad58-d1d28a95e5aa	16
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	14767ff8-7803-4922-ac03-ff80c061e5ba	16
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	14767ff8-7803-4922-ac03-ff80c061e5ba	16
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	c2307cc2-43ee-4319-ad58-d1d28a95e5aa	16
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	4e12b7e1-fa2f-4cd1-ada6-19a7d5652348	15
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	4e12b7e1-fa2f-4cd1-ada6-19a7d5652348	15
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	4e12b7e1-fa2f-4cd1-ada6-19a7d5652348	15
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	29df8839-3dfa-0b2b-c5a3-906db6997b3b	10
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	29df8839-3dfa-0b2b-c5a3-906db6997b3b	10
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	29df8839-3dfa-0b2b-c5a3-906db6997b3b	10
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	29df8839-3dfa-0b2b-c5a3-906db6997b3b	10
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	29df8839-3dfa-0b2b-c5a3-906db6997b3b	10
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	29df8839-3dfa-0b2b-c5a3-906db6997b3b	10
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	41529314-b203-47f4-88dd-5aa57c74985f	7
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	41529314-b203-47f4-88dd-5aa57c74985f	7
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	41529314-b203-47f4-88dd-5aa57c74985f	7
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	7f25bff3-0e86-4bec-b293-54b68347867f	6
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	7f25bff3-0e86-4bec-b293-54b68347867f	6
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	7f25bff3-0e86-4bec-b293-54b68347867f	6
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	7f25bff3-0e86-4bec-b293-54b68347867f	6
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	7f25bff3-0e86-4bec-b293-54b68347867f	6
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	7f25bff3-0e86-4bec-b293-54b68347867f	6
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	b000150f-3be6-2e6c-e053-2995a90a67d5	5
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	29e83667-8d4a-49b7-9182-653cbfb2dee7	5
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	a56a7056-c72a-4e25-9c41-327f429e7af0	5
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	a56a7056-c72a-4e25-9c41-327f429e7af0	5
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	29e83667-8d4a-49b7-9182-653cbfb2dee7	5
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	b000150f-3be6-2e6c-e053-2995a90a67d5	5
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	b000150f-3be6-2e6c-e053-2995a90a67d5	5
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	a56a7056-c72a-4e25-9c41-327f429e7af0	5
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	29e83667-8d4a-49b7-9182-653cbfb2dee7	5
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	56de2d42-5cb5-4634-a1f8-f1c8397b02ed	4
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	f7f97520-d063-ec87-e053-6294a90aae0c	4
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	46dc8f62-e700-50e3-e054-00144ff8d46c	4
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	46dc8f62-e700-50e3-e054-00144ff8d46c	4
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	56de2d42-5cb5-4634-a1f8-f1c8397b02ed	4
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	f7f97520-d063-ec87-e053-6294a90aae0c	4
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	56de2d42-5cb5-4634-a1f8-f1c8397b02ed	4
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	46dc8f62-e700-50e3-e054-00144ff8d46c	4
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	f7f97520-d063-ec87-e053-6294a90aae0c	4
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	505ee941-2962-35e4-e054-00144ff88e88	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	3ed6bf70-2841-04f8-e054-00144ff8d46c	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	505ee941-2962-35e4-e054-00144ff88e88	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	3ed6bf70-2841-04f8-e054-00144ff8d46c	3
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	505ee941-2962-35e4-e054-00144ff88e88	3
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	3ed6bf70-2841-04f8-e054-00144ff8d46c	3
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	32e2b197-e171-444d-86ca-198d4c84d7a5	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	5488e98e-3955-017c-e054-00144ff8d46c	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	9003c06e-5d28-af7e-e053-2995a90ad432	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	32e2b197-e171-444d-86ca-198d4c84d7a5	2
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	32e2b197-e171-444d-86ca-198d4c84d7a5	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	9003c06e-5d28-af7e-e053-2995a90ad432	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	32e2b197-e171-444d-86ca-198d4c84d7a5	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	5488e98e-3955-017c-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-420-01	65862042001	100 TABLET in 1 BOTTLE (65862-420-01)	100 tablet	2010-02-16	0000-00-00	No	No	Current
65862-420-05	65862042005	500 TABLET in 1 BOTTLE (65862-420-05)	500 tablet	2010-02-16	0000-00-00	No	No	Current
65862-420-12	65862042012	12500 TABLET in 1 BAG (65862-420-12)	12500 tablet	24-JUL-19				Current
65862-420-15	65862042015	1500 TABLET in 1 BAG (65862-420-15)	1500 tablet	16-FEB-10				Current
65862-420-20	65862042020	20 TABLET in 1 BOTTLE (65862-420-20)	20 tablet	2010-02-16	0000-00-00	No	No	Current
65862-420-99	65862042099	1000 TABLET in 1 BOTTLE (65862-420-99)	1000 tablet	2010-02-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim Tablets, USP	Unit Dose Solutions, Inc.	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	1
Sulfamethoxazole and Trimethoprim Tablets, USP	AvPAK	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	10
Sulfamethoxazole and Trimethoprim Tablets, USP	REMEDYREPACK INC.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	21
Sulfamethoxazole and Trimethoprim Tablets, USP	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Sulfamethoxazole and Trimethoprim Tablets, USP	QPharma, Inc. \| Northwind Health Company, LLC	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	7
Sulfamethoxazole and Trimethoprim Tablets, USP 800/160MG	VERITYRX, LLC	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	1
Sulfamethoxazole and Trimethoprim Tablets, USP 8460321/0325	American Health Packaging	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	6
Sulfamethoxazole and Trimethoprim Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2025-04-30	HUMAN PRESCRIPTION DRUG LABEL	20
Sulfamethoxazole and Trimethoprim Tablets, USP	A-S Medication Solutions	2025-04-01	Human Prescription Drug Label	21
Sulfamethoxazole and Trimethoprim Tablets, USP	A-S Medication Solutions	2025-03-31	Human Prescription Drug Label	19
Sulfamethoxazole and Trimethoprim Tablets, USP	A-S Medication Solutions	2025-03-31	Human Prescription Drug Label	16
Sulfamethoxazole and Trimethoprim Tablets, USP	A-S Medication Solutions	2025-03-31	Human Prescription Drug Label	15
Sulfamethoxazole and Trimethoprim Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2025-03-26	HUMAN PRESCRIPTION DRUG LABEL	26
Sulfamethoxazole and Trimethoprim Tablets, USP	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-03-12	Human Prescription Drug Label	17
Sulfamethoxazole and Trimethoprim 800mg/160mg Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	5
Sulfamethoxazole and Trimethoprim Tablets, USP	Coupler LLC	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	1
Sulfamethoxazole and Trimethoprim Tablets, USP	Preferred Pharmaceuticals Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	7
Sulfamethoxazole and Trimethoprim Tablets, USP	NuCare Pharmaceuticals, Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	4
Sulfamethoxazole and Trimethoprim Tablets, USP	NuCare Pharmaceuticals, Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	3
Sulfamethoxazole and Trimethoprim Tablets, USP	NCS HealthCare of KY, LLC dba Vangard Labs	2024-02-05	HUMAN PRESCRIPTION DRUG LABEL	16
Sulfamethoxazole and Trimethoprim Tablets, USP	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	5
Sulfamethoxazole and Trimethoprim Tablets, USP	A-S Medication Solutions	2023-02-04	Human Prescription Drug Label	17