Sulfamethoxazole and Trimethoprim

Product NDC: 61971-120
11-digit product format: 619710120
Labeler code: 61971
Product ID: 61971-120_69d5e1fe-d9e9-4afa-bd62-8df032a34d32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: Vista Pharmaceuticals, Inc.
Application: ANDA076817
Marketing category: ANDA
Marketing start: 2006-08-22
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

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
A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB		2005-10-07
A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB		2005-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076817-001	AB
A076817-002	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	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`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	A076817-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076817-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076817-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076817-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076817-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076817-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076817-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076817-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076817-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076817-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076817-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076817-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076817-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076817-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076817-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076817-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076817-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076817-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076817-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076817-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076817-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076817-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076817-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076817-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076817-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076817-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076817-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076817-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076817-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076817-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076817-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076817-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076817-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076817-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076817-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076817-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076817-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076817-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076817-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076817-002	AB	1	`bb7c543d1eb4…`

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
JE42381TNV	Internal UNII lookup
AN164J8Y0X	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
3edca473-8fdc-462a-b378-6c3279503a70	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
6e20c430-5e8f-85da-1b03-f7dbc0c51fad	Product name	3	20190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61971-120-01	Sulfamethoxazole and Trimethoprim	100 in 1 BOTTLE	TABLET	100		8
61971-120-05	Sulfamethoxazole and Trimethoprim	500 in 1 BOTTLE	TABLET	500		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61971-120-01	EA - Each	61971-120	946e35d0-3b29-490b-b09e-93ec6a227227	1	2013-02-13
61971-120-05	EA - Each	61971-120	1c110c15-5ba0-4c8d-98d1-753d392a40fd	1	2013-02-13

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.]	7
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	7
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	7
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	7
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]	5
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]	5
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]	5
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]	5
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]	5
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]	5
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]	5
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]	5
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]	3
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]	3
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]	3
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]	3
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [NORTHWIND PHARMACEUTICALS]	2
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [NORTHWIND PHARMACEUTICALS]	2
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [NORTHWIND PHARMACEUTICALS]	2
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [NORTHWIND PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61971-120	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [VISTA PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20200123_3edca473-8fdc-462a-b378-6c3279503a70.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Proficient Rx LP	c407381f-3d8e-4fdf-9132-cd3968099296	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076817 application number: ANDA076817
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Vista Pharmaceuticals, Inc.	3edca473-8fdc-462a-b378-6c3279503a70	2020-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076817 application number: ANDA076817 ndc (product): 61971-120

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	3edca473-8fdc-462a-b378-6c3279503a70	8
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	3edca473-8fdc-462a-b378-6c3279503a70	8
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	c407381f-3d8e-4fdf-9132-cd3968099296	8
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	3edca473-8fdc-462a-b378-6c3279503a70	8
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	c407381f-3d8e-4fdf-9132-cd3968099296	8
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	3edca473-8fdc-462a-b378-6c3279503a70	8
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	3edca473-8fdc-462a-b378-6c3279503a70	8
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	c407381f-3d8e-4fdf-9132-cd3968099296	8
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	3edca473-8fdc-462a-b378-6c3279503a70	8
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	17c7ace2-6f06-4111-e054-00144ff88e88	7
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	17c7ace2-6f06-4111-e054-00144ff88e88	7
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	17c7ace2-6f06-4111-e054-00144ff88e88	7
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	4180c1d6-1aac-470e-e054-00144ff88e88	4
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	4180c1d6-1aac-470e-e054-00144ff88e88	4
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	4180c1d6-1aac-470e-e054-00144ff88e88	4
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	a0f86f52-8841-4e1c-8536-2e78320471ed	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	a0f86f52-8841-4e1c-8536-2e78320471ed	3
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	a0f86f52-8841-4e1c-8536-2e78320471ed	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61971-120-01	61971012001	100 TABLET in 1 BOTTLE (61971-120-01)	100 tablet	2006-08-22	0000-00-00	No	No	Current
61971-120-05	61971012005	500 TABLET in 1 BOTTLE (61971-120-05)	500 tablet	2006-08-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	4
Sulfamethoxazole and Trimethoprim Tablets, USP R	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-13	HUMAN PRESCRIPTION DRUG LABEL	4
Sulfamethoxazole and Trimethoprim Tablets, USP	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	8
Sulfamethoxazole and Trimethoprim Tablets, USP	NuCare Pharmaceuticals, Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	2
Sulfamethoxazole and Trimethoprim Tablets, USP R	Vista Pharmaceuticals, Inc. \| Vista Pharmaceuticals, Limited.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	8
Sulfamethoxazole and Trimethoprim Tablets, USP R	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	5
Sulfamethoxazole and Trimethoprim Tablets, USP	Preferred Pharmaceuticals, Inc.	2019-03-29	HUMAN PRESCRIPTION DRUG LABEL	6
SULFAMETHOXAZOLE AND TRIMETHOPRIM	Direct Rx	2015-11-02	HUMAN PRESCRIPTION DRUG LABEL	3
Sulfamethoxazole and Trimethoprim Tablets, USP	Blenheim Pharmacal, Inc.	2015-06-05	HUMAN PRESCRIPTION DRUG LABEL	7
Sulfamethoxazole and Trimethoprim - Northwind Pharmaceuticals	Northwind Pharmaceuticals	2014-11-10	HUMAN PRESCRIPTION DRUG LABEL	2