SULFATRIM

Product NDC: 68788-7083
11-digit product format: 687887083
Labeler code: 68788
Product ID: 68788-7083_495713e8-a34c-48a5-8d89-d8b3c125a140
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: SUSPENSION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: NDA018615
Marketing category: NDA
Marketing start: 2018-01-25
Marketing end: 0000-00-00
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 200 mg/5mL; mg/5mL
Pharmacologic classes: Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-7083		D	Discontinued by firm		2026-08-10
excluded package	package	68788-7083	68788-7083-4	D	Discontinued by firm		2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7083-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7083-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-7083-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-7083-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-7083-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-7083-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-7083-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-7083-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7083-4	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-7083-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68788-7083-4	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68788-7083-4	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N018615-001	SULFATRIM PEDIATRIC	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		1983-01-07
N018615-002	SULFATRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL			1983-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018615-001	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	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018615-001	SULFATRIM PEDIATRIC	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	1983-01-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018615-002	SULFATRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		1983-01-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N018615-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018615-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018615-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018615-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018615-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018615-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018615-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018615-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018615-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018615-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018615-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018615-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018615-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018615-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018615-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018615-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018615-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018615-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018615-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018615-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018615-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018615-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018615-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018615-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018615-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018615-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018615-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018615-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018615-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018615-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018615-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018615-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018615-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018615-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018615-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018615-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018615-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018615-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018615-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018615-001	AB	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SULFATRIM	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	80f7f00b-add4-4d6b-9e9c-bea29768c239	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018615 application number: NDA018615
SULFATRIM	SULFAMETHOXAZOLE AND TRIMETHOPRIM	PAI Holdings, LLC dba PAI Pharma	c62086ea-ba15-40f5-8431-4639c60c9825	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018615 application number: NDA018615
SULFATRIM	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Preferred Pharmaceuticals, Inc.	cd4932ce-0856-4e99-8baf-70afce1d7ffd	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018615 application number: NDA018615
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	PAI Holdings, LLC dba PAI Pharma	777da85a-a776-4681-976d-326ec421cfc9	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018615 application number: NDA018615

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SULFATRIM TM (Sulfamethoxazole and Trimethoprim Oral Suspension, USP)	Preferred Pharmaceuticals Inc.	2019-03-29	HUMAN PRESCRIPTION DRUG LABEL	2