Sulfamethoxazole and Trimethoprim

Product NDC
53746-271
11-digit product format
537460271
Labeler code
53746
Product ID
53746-271_bc5fe496-071b-4c25-95da-14c6c561e79e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-02-25
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
400; 80 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 1.

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
A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27
A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076899-001AB
A076899-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076899-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076899-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076899-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076899-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076899-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076899-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076899-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076899-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076899-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076899-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076899-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076899-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076899-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076899-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076899-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076899-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076899-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076899-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076899-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076899-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076899-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076899-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076899-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076899-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076899-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076899-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076899-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076899-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076899-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076899-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076899-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076899-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076899-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076899-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076899-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076899-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076899-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076899-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076899-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076899-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE400 mg/1
TRIMETHOPRIM80 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198334Internal RxNorm lookup
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
3233c54d-484d-4550-b172-db8af47d1b7fAvailable 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
53746-271-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET10019
53746-271-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET50019
53746-271-10Sulfamethoxazole and Trimethoprim1000 in 1 BOTTLETABLET100019
53746-271-50Sulfamethoxazole and Trimethoprim50 in 1 BOTTLETABLET5019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-271-01EA - Each53746-2714c3013c0-5ee6-4057-8a4a-c7d9cd8d8f4212012-07-24
53746-271-05EA - Each53746-27145dcf3ff-6233-4236-b493-7c2d6898cd1412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]4
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]4
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]4
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]4
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [KAISER FOUNDATION HOSPITALS]1
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [KAISER FOUNDATION HOSPITALS]1
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [KAISER FOUNDATION HOSPITALS]1
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [KAISER FOUNDATION HOSPITALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [KAISER FOUNDATION HOSPITALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [KAISER FOUNDATION HOSPITALS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [KAISER FOUNDATION HOSPITALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [KAISER FOUNDATION HOSPITALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-271SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]19Current NDC, Legacy NDC, 4 package rows20250321_3233c54d-484d-4550-b172-db8af47d1b7f.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmneal Pharmaceuticals LLCf0e73842-6002-43c2-97fc-0cadc1bf63462026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAvKARE9f130443-c8e7-9122-8f27-f72f07f3f29e2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLCf2b8e9d9-1274-22ca-e053-2a95a90a6f1a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCardinal Health 107, LLC5dc03027-cdaf-461f-87fd-630d382fc7232025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMMajor Pharmaceuticalsabe0d2d5-4879-4b4e-9b57-47ea83a17ba02025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d2025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmneal Pharmaceuticals of New York LLC3233c54d-484d-4550-b172-db8af47d1b7f2025-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
ndc (product): 53746-271
Sulfamethoxazole and Trimethoprim DSSULFAMETHOXAZOLE AND TRIMETHOPRIMAdvanced Rx Pharmacy of Tennessee, LLCb001e648-2710-3ada-e053-2995a90a52f12024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMBryant Ranch Prepacka174991a-53e7-c791-3cee-b706a48e0ec52024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsf39a4c93-0a0e-4801-aecc-c55a2fa5e68b2024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsffc5d594-429c-4303-b3b6-f5a83e915b552024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions07a49665-fe2a-4a92-a57e-49db224b012e2024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions8661e318-ddf3-4a60-8781-6fa42307c60a2024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsb85a58a7-74d6-4629-8027-0cdcbb5c815a2023-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions07da67b1-b50c-4471-8cde-8a119eb8c9352023-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethox-TMP DSSULFAMETHOXAZOLE, TRIMETHOPRIMPharmPak, Inc.ede74118-32c5-4f52-9823-509538e674c82022-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LP0df74ba1-1aa6-467c-92e7-6b017c7c6bce2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN3233c54d-484d-4550-b172-db8af47d1b7f19
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3233c54d-484d-4550-b172-db8af47d1b7f19
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD3233c54d-484d-4550-b172-db8af47d1b7f19
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3233c54d-484d-4550-b172-db8af47d1b7f19
198334SMX 400 MG / TMP 80 MG Oral TabletSY3233c54d-484d-4550-b172-db8af47d1b7f19
198335SMX 800 MG / TMP 160 MG Oral TabletSY3233c54d-484d-4550-b172-db8af47d1b7f19
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN9f130443-c8e7-9122-8f27-f72f07f3f29e12
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN9f130443-c8e7-9122-8f27-f72f07f3f29e12
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD9f130443-c8e7-9122-8f27-f72f07f3f29e12
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD9f130443-c8e7-9122-8f27-f72f07f3f29e12
198334SMX 400 MG / TMP 80 MG Oral TabletSY9f130443-c8e7-9122-8f27-f72f07f3f29e12
198335SMX 800 MG / TMP 160 MG Oral TabletSY9f130443-c8e7-9122-8f27-f72f07f3f29e12
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN407fe0e4-f1e9-4876-e054-00144ff88e884
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD407fe0e4-f1e9-4876-e054-00144ff88e884
198334SMX 400 MG / TMP 80 MG Oral TabletSY407fe0e4-f1e9-4876-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-271-0153746027101100 TABLET in 1 BOTTLE (53746-271-01) 100 tablet2010-02-250000-00-00NoNoCurrent
53746-271-0553746027105500 TABLET in 1 BOTTLE (53746-271-05) 500 tablet2010-02-250000-00-00NoNoCurrent
53746-271-10537460271101000 TABLET in 1 BOTTLE (53746-271-10) 1000 tablet2010-02-250000-00-00NoNoCurrent
53746-271-505374602715050 TABLET in 1 BOTTLE (53746-271-50) 50 tablet2010-02-250000-00-00NoNoCurrent