Sulfamethoxazole and Trimethoprim

Product NDC: 55700-611
Requested package NDC: 55700-611-30
11-digit product format: 557000611
Labeler code: 55700
Product ID: 55700-611_b44a332e-98a1-4f1b-b06b-3a9b044cb926
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products LLC
Application: ANDA090624
Marketing category: ANDA
Marketing start: 2018-05-04
Marketing end: 2028-11-30
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55700-611	55700-611-30	D	Discontinued by firm		2026-08-03

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`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	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…`
2022-03-09 01:35 UTC	2022-03	A090624-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090624-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090624-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090624-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sulfamethoxazole and Trimethoprim

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
079c828c-148f-45b9-966e-d8906043b2a2	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
55700-611-06	Sulfamethoxazole and Trimethoprim	6 in 1 BOTTLE	TABLET	6	12
55700-611-10	Sulfamethoxazole and Trimethoprim	10 in 1 BOTTLE	TABLET	10	12
55700-611-14	Sulfamethoxazole and Trimethoprim	14 in 1 BOTTLE	TABLET	14	12
55700-611-20	Sulfamethoxazole and Trimethoprim	20 in 1 BOTTLE	TABLET	20	12
55700-611-28	Sulfamethoxazole and Trimethoprim	28 in 1 BOTTLE	TABLET	28	12
55700-611-30	Sulfamethoxazole and Trimethoprim	30 in 1 BOTTLE	TABLET	30	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-611-06	EA - Each	55700-611	966445f2-28b0-4c4f-ad3a-4f6308ab54c5	1	2019-02-13
55700-611-10	EA - Each	55700-611	2d61ab8e-7be8-40ee-9009-4a3e7659e39f	1	2018-06-11
55700-611-14	EA - Each	55700-611	525aaaa8-948e-4c03-bcdf-2825896500a8	1	2018-06-11
55700-611-20	EA - Each	55700-611	840735f2-d4a9-4a27-9445-c212e84b5eae	1	2018-06-11
55700-611-28	EA - Each	55700-611	909eaf73-9a26-402a-8e16-ef5e39bcfdc8	1	2018-06-11
55700-611-30	EA - Each	55700-611	e8b39231-f46a-41fe-9cdc-bf57f0c2ff9b	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-611	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [QUALITY CARE PRODUCTS LLC]	12	Current NDC, Legacy NDC, 6 package rows	20241219_079c828c-148f-45b9-966e-d8906043b2a2.zip

openFDA label cross-check#

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

Matched openFDA labels page 1 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	c45ac3a4-d397-486e-abd1-349916543068	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Cardinal Health 107, LLC	08500fcb-dbec-4ac2-91c3-189d27907ec0	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Unit Dose Solutions, Inc.	562e2547-db2d-e2d2-e063-6294a90a1f5d	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	St. Mary's Medical Park Pharmacy	e3a49508-0ebe-1334-e053-2a95a90ae173	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Coupler LLC	518cc045-a12b-f08f-e063-6394a90acb0c	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	ce44959b-4bfe-4ba9-9fc2-7f9d4663d542	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	AvPAK	29df8839-3dfa-0b2b-c5a3-906db6997b3b	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	75b9d194-b960-4943-bedc-96e3d65c4da9	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	7f82e5e0-b627-a3f3-e053-2991aa0abaa5	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Sportpharm LLC	52304e5e-d097-48f2-8b64-210908e4eb54	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	99e1ace6-7665-4f87-82fd-5e7c4989e098	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	ec2e335c-3357-40d8-9615-a09fc40ce5f4	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfameth/Trimeth-DS	SULFAMETH/TRIMETH-DS	Direct_Rx	90026ce8-3305-6272-e053-2995a90a57e0	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	8c3e4738-0e0a-a854-e053-2995a90a7d71	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	f7f97520-d063-ec87-e053-6294a90aae0c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	471c5995-a4df-fbe3-e063-6394a90aa50e	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	QPharma, Inc.	41529314-b203-47f4-88dd-5aa57c74985f	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	VERITYRX, LLC	427b8040-99a4-8e81-e063-6394a90a76c5	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	1274cefb-0799-e2e4-e063-6394a90aad02	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Preferred Pharmaceuticals Inc.	d60c218c-6529-4944-af0b-a9dc720f32e9	2025-09-24	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	079c828c-148f-45b9-966e-d8906043b2a2	12
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	079c828c-148f-45b9-966e-d8906043b2a2	12
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	079c828c-148f-45b9-966e-d8906043b2a2	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-611-30	55700061130	30 TABLET in 1 BOTTLE (55700-611-30)	30 tablet	2018-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim Tablets, USP	Quality Care Products LLC	2024-12-17	Human Prescription Drug Label	12