Sulfamethoxazole and Trimethoprim

Product NDC: 65862-419
11-digit product format: 658620419
Labeler code: 65862
Product ID: 65862-419_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: 400; 80 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	65862-419		UNFINISHED	Active or certified unfinished drug listing	2026-10-05
unfinished package	package	65862-419	65862-419-25	UNFINISHED	Active or certified unfinished drug listing	2026-10-05
unfinished package	package	65862-419	65862-419-39	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	65862-419-25	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-419-39	`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	65862-419-25	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-419-39	`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	65862-419-25	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-419-39	`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	65862-419-25	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-419-39	`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	65862-419-25	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-419-39	`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	65862-419-25	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-419-39	`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	65862-419-25	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-419-39	`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	65862-419-25	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-419-39	`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	65862-419-25	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-419-39	`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	65862-419-25	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-419-39	`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	65862-419-25	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-419-39	`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	65862-419-25	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-419-39	`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	65862-419-25	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-419-39	`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	65862-419-25	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-419-39	`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	65862-419-25	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-419-39	`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	65862-419-39	`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	65862-419-39	`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	65862-419-39	`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	65862-419-39	`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	65862-419-39	`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	400 mg/1
TRIMETHOPRIM	80 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
65862-419-01	Sulfamethoxazole and Trimethoprim	100 in 1 BOTTLE	TABLET	100	17
65862-419-05	Sulfamethoxazole and Trimethoprim	500 in 1 BOTTLE	TABLET	500	17
65862-419-20	Sulfamethoxazole and Trimethoprim	20 in 1 BOTTLE	TABLET	20	17
65862-419-99	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
65862-419-01	EA - Each	65862-419	2de6c52c-d852-4951-b6fb-e7de58458ec0	1	2012-07-24
65862-419-05	EA - Each	65862-419	321adcf1-dce5-46cb-aab9-5788bd8d48fe	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 TABLET [AVPAK]	2
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]	2
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]	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 [UNIT DOSE SERVICES]	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 (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]	2
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]	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 [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]	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 [UNIT DOSE SERVICES]	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 [UNIT DOSE SERVICES]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-419	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 2 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	American Health Packaging	7f25bff3-0e86-4bec-b293-54b68347867f	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	PD-Rx Pharmaceuticals, Inc.	c4da9c4f-0704-4ed5-9d19-5c949f37f726	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Cronus Pharma LLC	1b5de94f-973a-4b5a-91d7-45e05be78650	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Rising Pharma Holdings, Inc.	e1a3748d-ca73-4e56-95ad-d25189cc346e	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	62616708-a538-459f-9b7f-ed90c6aa5fc6	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	14767ff8-7803-4922-ac03-ff80c061e5ba	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	fd90d8bd-1b84-4347-a98a-f8f94746f3e4	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	4e12b7e1-fa2f-4cd1-ada6-19a7d5652348	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	PD-Rx Pharmaceuticals, Inc.	3ef62512-0dc3-4821-9b60-6b375841c4c0	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Aurobindo Pharma Limited	284b5dac-2b8d-46bf-95fe-80ce03fa178a	2025-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624 ndc (product): 65862-419
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	8c74ea5c-d05e-4fc1-b980-aacaab56d472	2025-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	20054147-811c-471a-8ec4-1b2903fe906e	2025-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	a12fb7b0-9ff5-48f1-8fd9-4fbdfdbe09bc	2025-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim DS	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Advanced Rx Pharmacy of Tennessee, LLC	afe8cb1c-7cfd-3378-e053-2a95a90a4db6	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim DS	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Advanced Rx Pharmacy of Tennessee, LLC	b000150f-3be6-2e6c-e053-2995a90a67d5	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Quality Care Products LLC	079c828c-148f-45b9-966e-d8906043b2a2	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	7d7ca48b-8655-4cfb-8db0-28eddf1feb9b	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Bryant Ranch Prepack	27bebe39-c069-4a9d-99d1-c7cf44ac2f41	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals, Inc.	3ed6bf70-2841-04f8-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals, Inc.	46dc8f62-e700-50e3-e054-00144ff8d46c	2024-08-14	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
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
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
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
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
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
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	2d510d20-dd62-4b7a-b925-a3b71256a049	4
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	2d510d20-dd62-4b7a-b925-a3b71256a049	4
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	2d510d20-dd62-4b7a-b925-a3b71256a049	4
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	32e2b197-e171-444d-86ca-198d4c84d7a5	2
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	5c51042b-892c-f688-e053-2a91aa0a44d9	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
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	5c51042b-892c-f688-e053-2a91aa0a44d9	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	32e2b197-e171-444d-86ca-198d4c84d7a5	2
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	32e2b197-e171-444d-86ca-198d4c84d7a5	2
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	5c51042b-892c-f688-e053-2a91aa0a44d9	2
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	32e2b197-e171-444d-86ca-198d4c84d7a5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-419-01	65862041901	100 TABLET in 1 BOTTLE (65862-419-01)	100 tablet	2010-02-16	0000-00-00	No	No	Current
65862-419-05	65862041905	500 TABLET in 1 BOTTLE (65862-419-05)	500 tablet	2010-02-16	0000-00-00	No	No	Current
65862-419-20	65862041920	20 TABLET in 1 BOTTLE (65862-419-20)	20 tablet	2010-02-16	0000-00-00	No	No	Current
65862-419-25	65862041925	25000 TABLET in 1 BAG (65862-419-25)	25000 tablet	24-JUL-19				Current
65862-419-39	65862041939	3000 TABLET in 1 BAG (65862-419-39)	3000 tablet	16-FEB-10				Current
65862-419-99	65862041999	1000 TABLET in 1 BOTTLE (65862-419-99)	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	AvPAK	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	10
Sulfamethoxazole and Trimethoprim Tablets, USP 8460321/0325	American Health Packaging	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	6
Sulfamethoxazole and Trimethoprim Tablets, USP	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-03-12	Human Prescription Drug Label	17
sulfa/tmp 400/80	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
Sulfamethoxazole and Trimethoprim Tablets, USP	Unit Dose Services	2017-03-06	Human Prescription Drug Label	4
Sulfamethoxazole and Trimethoprim Tablets, USP	Physicians Total Care, Inc.	2010-11-23	Human Prescription Drug Label	2