Sulfamethoxazole and Trimethoprim

Product NDC
60687-442
Requested package NDC
60687-442-75
11-digit product format
606870442
Labeler code
60687
Product ID
60687-442_3546bee9-e4fa-333e-e063-6394a90a4200
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA091348
Marketing category
ANDA
Marketing start
2024-11-07
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
2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091348-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS2010-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-083f01610625f2…
2019-09-15 20:21 UTC2019-09A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091348-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2010-06-08cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091348-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091348-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091348-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091348-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091348-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091348-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091348-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091348-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091348-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091348-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091348-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091348-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091348-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091348-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091348-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091348-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091348-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091348-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091348-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091348-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091348-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091348-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091348-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091348-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091348-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091348-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091348-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091348-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091348-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091348-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091348-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091348-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091348-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091348-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091348-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091348-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091348-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091348-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091348-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091348-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE200 mg/5mL
TRIMETHOPRIM40 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JE42381TNVInternal UNII lookup
AN164J8Y0XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313134Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f14b8d07-e73b-4ceb-bd6a-578c961b7c09Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-442-24Sulfamethoxazole and Trimethoprim20 mL in 1 CUP, UNIT-DOSESUSPENSION203
60687-442-53Sulfamethoxazole and Trimethoprim10 in 1 TRAYSUSPENSION103
60687-442-75Sulfamethoxazole and Trimethoprim4 in 1 CASESUSPENSION43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-442-24ML - Milliliter60687-4420704f966-2e77-4675-b65f-1d7436223c0612024-10-04
60687-442-75ML - Milliliter60687-442ae280cfa-66bc-438f-8bb0-2b83304334e612024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-442SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AMERICAN HEALTH PACKAGING]3Current NDC, 3 package rows20250521_f14b8d07-e73b-4ceb-bd6a-578c961b7c09.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions69af86b4-9c9f-4a70-b448-97b36698f3cd2026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091348
application number: ANDA091348
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMATLANTIC BIOLOGICALS CORP.acc3df02-1e99-46e6-8a31-9b26261c6daa2025-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091348
application number: ANDA091348
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmerican Health Packagingf14b8d07-e73b-4ceb-bd6a-578c961b7c092025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091348
application number: ANDA091348
ndc (package): 60687-442-75
ndc (product): 60687-442
ndc11 (package): 60687044275
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAurobindo Pharma Limiteda6182855-6287-45e9-b6b4-7b57efc9c76e2024-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091348
application number: ANDA091348

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-442-75606870442754 TRAY in 1 CASE (60687-442-75) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-442-53) / 20 mL in 1 CUP, UNIT-DOSE (60687-442-24) 4 tray2024-11-07NoNoCurrent