Sulfamethoxazole and Trimethoprim

Product NDC: 53489-146
Requested package NDC: 53489-146-01
11-digit product format: 534890146
Labeler code: 53489
Product ID: 53489-146_31dd7abe-e7f2-10df-e063-6394a90a93e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA071017
Marketing category: ANDA
Marketing start: 1986-08-25
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB		1986-08-25
A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB		1986-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071017-001	AB
A071017-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071017-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071017-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071017-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071017-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071017-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071017-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071017-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071017-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071017-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071017-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071017-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071017-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071017-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071017-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071017-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071017-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071017-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071017-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071017-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071017-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071017-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071017-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071017-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071017-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071017-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071017-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071017-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071017-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071017-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071017-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071017-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071017-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071017-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071017-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071017-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071017-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071017-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071017-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071017-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071017-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	Golden State Medical Supply, Inc.	bd3161fe-23d7-458a-86a4-fb958d9c94d3	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071017 application number: ANDA071017
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Sun Pharmaceutical Industries, Inc.	4833319a-a7b3-4bf4-bec4-6531b43182d4	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071017 application number: ANDA071017 ndc (package): 53489-146-01 ndc (product): 53489-146 ndc11 (package): 53489014601

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
4833319a-a7b3-4bf4-bec4-6531b43182d4	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	Strength	SPL version
53489-146-01	Sulfamethoxazole and Trimethoprim	100 in 1 BOTTLE, PLASTIC	TABLET	100		19
53489-146-05	Sulfamethoxazole and Trimethoprim	500 in 1 BOTTLE, PLASTIC	TABLET	500		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53489-146-01	EA - Each	53489-146	2d10fea4-2154-41ea-b918-a6c8066dc5c8	1	2012-07-24
53489-146-05	EA - Each	53489-146	c3839166-a857-4eab-8f51-cd8f11d78227	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 [MUTUAL PHARMACEUTICAL COMPANY, INC.]	8
Trimethoprim	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	8
Sulfamethoxazole	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	8
Trimethoprim	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	8
Docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	8
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	8
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	8
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
Docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]	3
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	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 [NORTHWIND PHARMACEUTICALS]	2
Sulfamethoxazole	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]	2
Sulfamethoxazole	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NORTHWIND PHARMACEUTICALS]	2
Trimethoprim	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
Trimethoprim	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]	2
Sulfamethoxazole	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]	2
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NORTHWIND PHARMACEUTICALS]	2
Sulfamethoxazole	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
Trimethoprim	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NORTHWIND PHARMACEUTICALS]	2
Trimethoprim	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]	2
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
Sulfamethoxazole	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
Trimethoprim	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	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 [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
Trimethoprim	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
Docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	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 [GOLDEN STATE MEDICAL SUPPLY, INC.]	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 [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53489-146	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	19	Current NDC, Legacy NDC, 2 package rows	20250406_4833319a-a7b3-4bf4-bec4-6531b43182d4.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	4833319a-a7b3-4bf4-bec4-6531b43182d4	19
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	4833319a-a7b3-4bf4-bec4-6531b43182d4	19
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	4833319a-a7b3-4bf4-bec4-6531b43182d4	19
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	4833319a-a7b3-4bf4-bec4-6531b43182d4	19
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	4833319a-a7b3-4bf4-bec4-6531b43182d4	19
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	4833319a-a7b3-4bf4-bec4-6531b43182d4	19
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	bd3161fe-23d7-458a-86a4-fb958d9c94d3	12
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	bd3161fe-23d7-458a-86a4-fb958d9c94d3	12
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	bd3161fe-23d7-458a-86a4-fb958d9c94d3	12
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	bd3161fe-23d7-458a-86a4-fb958d9c94d3	12
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	bd3161fe-23d7-458a-86a4-fb958d9c94d3	12
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	bd3161fe-23d7-458a-86a4-fb958d9c94d3	12
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	4196e73b-5aec-2ede-e054-00144ff8d46c	5
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	4196e73b-5aec-2ede-e054-00144ff8d46c	5
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	4196e73b-5aec-2ede-e054-00144ff8d46c	5
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	3fcdd0a5-23e1-49c5-b9a7-f2c000cad1b2	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	d48ed3f0-d1dc-4548-95df-7786ce0f444a	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	6d829c49-4cc2-411f-aa13-67e20e30ebf4	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	3fcdd0a5-23e1-49c5-b9a7-f2c000cad1b2	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	d48ed3f0-d1dc-4548-95df-7786ce0f444a	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	6d829c49-4cc2-411f-aa13-67e20e30ebf4	3
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	3fcdd0a5-23e1-49c5-b9a7-f2c000cad1b2	3
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	d48ed3f0-d1dc-4548-95df-7786ce0f444a	3
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	6d829c49-4cc2-411f-aa13-67e20e30ebf4	3
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	49075f3d-eb10-464b-8ab9-5fad63246fbf	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	1fbbc3e5-ddc6-1e87-e054-00144ff8d46c	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	49075f3d-eb10-464b-8ab9-5fad63246fbf	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	1fbbc3e5-ddc6-1e87-e054-00144ff8d46c	2
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	49075f3d-eb10-464b-8ab9-5fad63246fbf	2
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	1fbbc3e5-ddc6-1e87-e054-00144ff8d46c	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	c996a6d3-fa66-4c84-bf0a-236b5001fb60	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	09f328ce-31d6-480f-88a6-846ac66fddbe	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	c996a6d3-fa66-4c84-bf0a-236b5001fb60	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	09f328ce-31d6-480f-88a6-846ac66fddbe	1
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	09f328ce-31d6-480f-88a6-846ac66fddbe	1
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	c996a6d3-fa66-4c84-bf0a-236b5001fb60	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53489-146-01	53489014601	100 TABLET in 1 BOTTLE, PLASTIC (53489-146-01)	100 tablet	1986-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim - Northwind Pharmaceuticals	Northwind Pharmaceuticals	2026-01-02	HUMAN PRESCRIPTION DRUG LABEL	3
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	Golden State Medical Supply, Inc.	2025-06-06	HUMAN PRESCRIPTION DRUG LABEL	12
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	Sun Pharmaceutical Industries, Inc. \| Frontida BioPharm, Inc. \| Alkaloida Chmeical Company Zrt.	2025-04-03	HUMAN PRESCRIPTION DRUG LABEL	19
Sulfamethoxazole and Trimethoprim - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	5
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	3
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	6
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	A-S Medication Solutions	2020-02-19	HUMAN PRESCRIPTION DRUG LABEL	10
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	A-S Medication Solutions	2020-02-19	HUMAN PRESCRIPTION DRUG LABEL	9
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	A-S Medication Solutions	2020-02-19	HUMAN PRESCRIPTION DRUG LABEL	7
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	McKesson Corporation dba SKY Packaging \| McKesson Corporation dba RX Pak	2019-09-10	HUMAN PRESCRIPTION DRUG LABEL	6
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	A-S Medication Solutions	2019-03-25	HUMAN PRESCRIPTION DRUG LABEL	10
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	A-S Medication Solutions	2018-08-03	HUMAN PRESCRIPTION DRUG LABEL	3
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	A-S Medication Solutions	2018-02-13	HUMAN PRESCRIPTION DRUG LABEL	4
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	Central Texas Community Health Centers	2017-08-31	HUMAN PRESCRIPTION DRUG LABEL	1
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	Central Texas Community Health Centers	2016-11-03	HUMAN PRESCRIPTION DRUG LABEL	1
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	Blenheim Pharmacal, Inc.	2016-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
SULFAMETHOXAZOLE AND TRIMETHOPRIM	DIRECT RX	2015-11-05	HUMAN PRESCRIPTION DRUG LABEL	3
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP	TYA Pharmaceuticals	2013-08-08	HUMAN PRESCRIPTION DRUG LABEL	2