FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
72789-018
11-digit product format
727890018
Labeler code
72789
Product ID
72789-018_3143fb81-1052-c193-e063-6394a90a18e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
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
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-16
A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090624-001AB
A090624-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-1684e616aacf4f…
2026-09-14 22:38:342026-08A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-1684e616aacf4f…
2026-08-18 06:07:402026-07A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-16caaa826d4ba7…
2026-08-18 06:07:402026-07A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-1674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090624-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090624-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090624-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090624-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090624-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090624-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090624-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090624-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090624-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090624-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090624-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090624-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090624-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090624-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090624-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090624-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090624-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090624-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090624-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090624-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090624-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090624-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090624-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090624-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090624-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090624-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090624-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090624-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090624-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090624-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090624-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090624-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090624-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090624-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090624-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090624-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090624-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090624-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090624-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090624-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE800 mg/1
TRIMETHOPRIM160 mg/1

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
198335Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ef62512-0dc3-4821-9b60-6b375841c4c0Available 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
72789-018-02Sulfamethoxazole and Trimethoprim2 in 1 BOTTLE, PLASTICTABLET226
72789-018-04Sulfamethoxazole and Trimethoprim4 in 1 BOTTLE, PLASTICTABLET426
72789-018-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET626
72789-018-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLE, PLASTICTABLET1026
72789-018-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET1426
72789-018-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET2026
72789-018-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLE, PLASTICTABLET2826
72789-018-40Sulfamethoxazole and Trimethoprim40 in 1 BOTTLE, PLASTICTABLET4026
72789-018-60Sulfamethoxazole and Trimethoprim60 in 1 BOTTLE, PLASTICTABLET6026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-018-02EA - Each72789-018ede706d1-dd84-4944-8a17-a6267099957812020-07-13
72789-018-04EA - Each72789-0180b12ebae-d70b-452f-94cf-3b3bdc05905812020-04-20
72789-018-06EA - Each72789-018b290d461-35be-4548-abc7-2293e3cf3b5612020-01-03
72789-018-10EA - Each72789-018ed380a50-6651-4210-8e15-16cb81fb7b2a12020-01-03
72789-018-14EA - Each72789-01804bd23bc-eb79-40ba-a291-7ec8a2b6d8b912020-01-03
72789-018-20EA - Each72789-018b80433c7-6624-41e9-acf0-cd82c52592de12020-01-03
72789-018-28EA - Each72789-0185936227f-78b8-4bd7-b9e2-86216431bb2912020-04-20
72789-018-40EA - Each72789-0180b4285a5-af9c-4b66-a9c3-c57e9efc851512020-01-03
72789-018-60EA - Each72789-018c1511091-d7da-4e90-a9da-823e9524a86b12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-018SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 9 package rows20250328_3ef62512-0dc3-4821-9b60-6b375841c4c0.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 3 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPharmasource Meds, LLCf564a029-4b20-301a-e053-2995a90adcc02024-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNCS HealthCare of KY, LLC dba Vangard Labsc2307cc2-43ee-4319-ad58-d1d28a95e5aa2024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LPbefcc5b0-04bb-4211-b3dd-88f400c7fa782023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsd8239804-d234-491b-965d-89a7796a5e4d2023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMDenton Pharma, Inc. DBA Northwind Pharmaceuticalsa12bf393-d8ef-48df-e053-2a95a90a1af12023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LP29e83667-8d4a-49b7-9182-653cbfb2dee72022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAsclemed USA, Inc.e6c0f80a-ba22-4690-aaf8-48a4602b68312020-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3ef62512-0dc3-4821-9b60-6b375841c4c026
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3ef62512-0dc3-4821-9b60-6b375841c4c026
198335SMX 800 MG / TMP 160 MG Oral TabletSY3ef62512-0dc3-4821-9b60-6b375841c4c026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-018-02727890018022 TABLET in 1 BOTTLE, PLASTIC (72789-018-02) 2 tablet2020-04-100000-00-00NoNoCurrent
72789-018-04727890018044 TABLET in 1 BOTTLE, PLASTIC (72789-018-04) 4 tablet2020-02-260000-00-00NoNoCurrent
72789-018-06727890018066 TABLET in 1 BOTTLE, PLASTIC (72789-018-06) 6 tablet2019-10-170000-00-00NoNoCurrent
72789-018-107278900181010 TABLET in 1 BOTTLE, PLASTIC (72789-018-10) 10 tablet2019-10-290000-00-00NoNoCurrent
72789-018-147278900181414 TABLET in 1 BOTTLE, PLASTIC (72789-018-14) 14 tablet2019-11-010000-00-00NoNoCurrent
72789-018-207278900182020 TABLET in 1 BOTTLE, PLASTIC (72789-018-20) 20 tablet2019-10-170000-00-00NoNoCurrent
72789-018-287278900182828 TABLET in 1 BOTTLE, PLASTIC (72789-018-28) 28 tablet2020-02-130000-00-00NoNoCurrent
72789-018-407278900184040 TABLET in 1 BOTTLE, PLASTIC (72789-018-40) 40 tablet2019-11-220000-00-00NoNoCurrent
72789-018-607278900186060 TABLET in 1 BOTTLE, PLASTIC (72789-018-60) 60 tablet2019-10-170000-00-00NoNoCurrent