SULFATRIM

Product NDC: 50090-7836
11-digit product format: 500907836
Labeler code: 50090
Product ID: 50090-7836_582e04ab-98bc-46c8-8e39-ccd2dccd4c2b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: SUSPENSION
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA018615
Marketing category: NDA
Marketing start: 1983-07-03
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 200; 40 mg/5mL; mg/5mL
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: SULFATRIM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULFAMETHOXAZOLE	200 mg/5mL
TRIMETHOPRIM	40 mg/5mL

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
208406	Internal RxNorm lookup
313134	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
80f7f00b-add4-4d6b-9e9c-bea29768c239	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
50090-7836-0	SULFATRIM	473 mL in 1 BOTTLE	SUSPENSION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7836-0	ML - Milliliter	50090-7836	a2e4527b-1c51-4af5-9a11-2c72131064f5	1	2026-02-05

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 ndc (product): 50090-7836
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313134	sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral Suspension	PSN	80f7f00b-add4-4d6b-9e9c-bea29768c239	2
208406	SULFATRIM 200 MG / 40 MG in 5 mL Oral Suspension	PSN	80f7f00b-add4-4d6b-9e9c-bea29768c239	2
208406	sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]	SBD	80f7f00b-add4-4d6b-9e9c-bea29768c239	2
313134	sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension	SCD	80f7f00b-add4-4d6b-9e9c-bea29768c239	2
313134	SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension	SY	80f7f00b-add4-4d6b-9e9c-bea29768c239	2
208406	SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]	SY	80f7f00b-add4-4d6b-9e9c-bea29768c239	2
313134	sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral Suspension	SY	80f7f00b-add4-4d6b-9e9c-bea29768c239	2
313134	sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral Suspension	SY	80f7f00b-add4-4d6b-9e9c-bea29768c239	2
313134	sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral Suspension	SY	80f7f00b-add4-4d6b-9e9c-bea29768c239	2
208406	Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral Suspension	SY	80f7f00b-add4-4d6b-9e9c-bea29768c239	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7836-0	50090783600	473 mL in 1 BOTTLE (50090-7836-0)	473 ml	2025-12-29	No	No	Current