Sulfamethoxazole and Trimethoprim

Product NDC: 67296-1129
11-digit product format: 672961129
Labeler code: 67296
Product ID: 67296-1129_d60feb9c-08c1-7a56-e053-2995a90a7892
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: SUSPENSION
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA091348
Marketing category: ANDA
Marketing start: 2010-06-08
Marketing end: 0000-00-00
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 200 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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67296-1129		I	Inactivated by FDA	2026-10-05
excluded package	package	67296-1129	67296-1129-1	I	Inactivated by FDA	2026-10-05
excluded package	package	67296-1129	67296-1129-2	I	Inactivated by FDA	2026-10-05

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 · 15 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1129-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1129-2	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1129-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1129-2	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1129-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1129-2	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1129-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1129-2	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1129-2	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1129-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091348-001	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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A091348-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091348-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091348-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091348-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091348-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091348-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091348-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091348-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091348-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091348-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091348-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091348-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091348-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091348-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091348-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091348-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091348-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091348-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091348-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091348-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091348-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091348-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091348-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091348-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091348-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091348-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091348-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091348-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091348-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091348-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091348-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091348-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091348-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091348-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091348-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091348-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091348-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091348-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091348-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091348-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
67296-1129-1	2026-01-29	4eb60cd1-612c-20ab-e054-00144ff88e88
67296-1129-2	2026-01-29	4eb60cd1-612c-20ab-e054-00144ff88e88
67296-1129-1	2024-07-15	4eb60cd1-612c-20ab-e054-00144ff88e88
67296-1129-2	2024-07-15	4eb60cd1-612c-20ab-e054-00144ff88e88
67296-1129-1	2024-01-30	4eb60cd1-612c-20ab-e054-00144ff88e88
67296-1129-2	2024-01-30	4eb60cd1-612c-20ab-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1129-1	Sulfamethoxazole and Trimethoprim	100 mL in 1 BOTTLE	SUSPENSION	100		6
67296-1129-2	Sulfamethoxazole and Trimethoprim	200 mL in 1 BOTTLE	SUSPENSION	200		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1129	SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REDPHARM DRUG, INC.]	6	Legacy NDC, 2 package rows	20240716_4eb60cd1-612c-20ab-e054-00144ff88e88.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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	ATLANTIC BIOLOGICALS CORP.	acc3df02-1e99-46e6-8a31-9b26261c6daa	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091348 application number: ANDA091348
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	69af86b4-9c9f-4a70-b448-97b36698f3cd	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091348 application number: ANDA091348
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	American Health Packaging	f14b8d07-e73b-4ceb-bd6a-578c961b7c09	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091348 application number: ANDA091348
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Aurobindo Pharma Limited	a6182855-6287-45e9-b6b4-7b57efc9c76e	2024-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091348 application number: ANDA091348

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	4eb60cd1-612c-20ab-e054-00144ff88e88	6
313134	sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension	SCD	4eb60cd1-612c-20ab-e054-00144ff88e88	6
313134	SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension	SY	4eb60cd1-612c-20ab-e054-00144ff88e88	6
313134	sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral Suspension	SY	4eb60cd1-612c-20ab-e054-00144ff88e88	6
313134	sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral Suspension	SY	4eb60cd1-612c-20ab-e054-00144ff88e88	6
313134	sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral Suspension	SY	4eb60cd1-612c-20ab-e054-00144ff88e88	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1129-1	67296112901	100 mL in 1 BOTTLE (67296-1129-1)	100 ml	2010-06-08	0000-00-00	No	No	Current
67296-1129-2	67296112902	200 mL in 1 BOTTLE (67296-1129-2)	200 ml	2010-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	6