Sulfamethoxazole and Trimethoprim

Product NDC: 71205-810
11-digit product format: 712050810
Labeler code: 71205
Product ID: 71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
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: 2027-12-31
Current FDA listing: Yes

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: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
befcc5b0-04bb-4211-b3dd-88f400c7fa78	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	SPL version
71205-810-06	Sulfamethoxazole and Trimethoprim	6 in 1 BOTTLE	TABLET	6	5
71205-810-10	Sulfamethoxazole and Trimethoprim	10 in 1 BOTTLE	TABLET	10	5
71205-810-14	Sulfamethoxazole and Trimethoprim	14 in 1 BOTTLE	TABLET	14	5
71205-810-20	Sulfamethoxazole and Trimethoprim	20 in 1 BOTTLE	TABLET	20	5
71205-810-28	Sulfamethoxazole and Trimethoprim	28 in 1 BOTTLE	TABLET	28	5
71205-810-30	Sulfamethoxazole and Trimethoprim	30 in 1 BOTTLE	TABLET	30	5
71205-810-40	Sulfamethoxazole and Trimethoprim	40 in 1 BOTTLE	TABLET	40	5
71205-810-60	Sulfamethoxazole and Trimethoprim	60 in 1 BOTTLE	TABLET	60	5
71205-810-90	Sulfamethoxazole and Trimethoprim	90 in 1 BOTTLE	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-810-06	EA - Each	71205-810	5abf4b64-576c-41c6-a47a-2c03a0a9f658	1	2023-12-05
71205-810-10	EA - Each	71205-810	8a379027-2560-4d13-ba15-1d70886a250a	1	2024-02-14
71205-810-14	EA - Each	71205-810	36d6696c-0bbc-4db0-8e89-2f12c05a03cb	1	2023-08-08
71205-810-20	EA - Each	71205-810	1cdd6b84-ad4c-4c96-8b58-d530bcde09f5	1	2023-12-05
71205-810-28	EA - Each	71205-810	438259e4-45a9-46d6-a4ea-786ecaae9cdf	1	2023-08-08
71205-810-40	EA - Each	71205-810	8f23746f-12c7-479e-a8d7-670a152048c2	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-810	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]	5	Current NDC, 9 package rows	20230825_befcc5b0-04bb-4211-b3dd-88f400c7fa78.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
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
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	befcc5b0-04bb-4211-b3dd-88f400c7fa78	5
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	befcc5b0-04bb-4211-b3dd-88f400c7fa78	5
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	befcc5b0-04bb-4211-b3dd-88f400c7fa78	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71205-810-06	71205081006	6 TABLET in 1 BOTTLE (71205-810-06)	6 tablet	2023-07-19	No	No	Current
71205-810-10	71205081010	10 TABLET in 1 BOTTLE (71205-810-10)	10 tablet	2023-05-31	No	No	Current
71205-810-14	71205081014	14 TABLET in 1 BOTTLE (71205-810-14)	14 tablet	2023-05-31	No	No	Current
71205-810-20	71205081020	20 TABLET in 1 BOTTLE (71205-810-20)	20 tablet	2023-06-02	No	No	Current
71205-810-28	71205081028	28 TABLET in 1 BOTTLE (71205-810-28)	28 tablet	2023-06-02	No	No	Current
71205-810-30	71205081030	30 TABLET in 1 BOTTLE (71205-810-30)	30 tablet	2023-05-31	No	No	Current
71205-810-40	71205081040	40 TABLET in 1 BOTTLE (71205-810-40)	40 tablet	2023-08-21	No	No	Current
71205-810-60	71205081060	60 TABLET in 1 BOTTLE (71205-810-60)	60 tablet	2023-05-31	No	No	Current
71205-810-90	71205081090	90 TABLET in 1 BOTTLE (71205-810-90)	90 tablet	2023-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim Tablets, USP	Proficient Rx LP	2023-08-01	HUMAN PRESCRIPTION DRUG LABEL	5