Sulfamethoxazole and Trimethoprim

Product NDC
53489-146
Requested package NDC
53489-146-05
11-digit product format
534890146
Labeler code
53489
Product ID
53489-146_31dd7abe-e7f2-10df-e063-6394a90a93e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA071017
Marketing category
ANDA
Marketing start
1986-08-25
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 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
A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25
A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071017-001AB
A071017-002AB

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 UTC2026-02A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25782e0a99824c…

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 UTC2026-02A071017-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071017-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071017-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071017-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071017-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071017-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071017-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071017-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071017-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071017-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071017-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071017-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071017-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071017-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071017-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071017-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071017-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071017-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071017-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071017-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071017-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071017-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071017-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071017-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071017-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071017-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071017-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071017-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071017-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071017-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071017-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071017-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071017-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071017-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071017-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071017-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071017-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071017-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071017-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A071017-002AB1782e0a99824c…

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
AN164J8Y0XInternal UNII lookup
JE42381TNVInternal 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
4833319a-a7b3-4bf4-bec4-6531b43182d4Available 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-146-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLE, PLASTICTABLET10019
53489-146-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLE, PLASTICTABLET50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-146-01EA - Each53489-1462d10fea4-2154-41ea-b918-a6c8066dc5c812012-07-24
53489-146-05EA - Each53489-146c3839166-a857-4eab-8f51-cd8f11d7822712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SulfamethoxazoleACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
TrimethoprimACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
SulfamethoxazoleACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
TrimethoprimACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
Docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
magnesium stearateINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
SulfamethoxazoleACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
TrimethoprimACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
Docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
magnesium stearateINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NORTHWIND PHARMACEUTICALS]2
SulfamethoxazoleACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]2
SulfamethoxazoleACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NORTHWIND PHARMACEUTICALS]2
TrimethoprimACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TrimethoprimACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]2
SulfamethoxazoleACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]2
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NORTHWIND PHARMACEUTICALS]2
SulfamethoxazoleACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TrimethoprimACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NORTHWIND PHARMACEUTICALS]2
TrimethoprimACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [TYA PHARMACEUTICALS]2
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
SulfamethoxazoleACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TrimethoprimACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
SulfamethoxazoleACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TrimethoprimACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
Docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-146SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]19Current NDC, Legacy NDC, 2 package rows20250406_4833319a-a7b3-4bf4-bec4-6531b43182d4.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMGolden State Medical Supply, Inc.bd3161fe-23d7-458a-86a4-fb958d9c94d32025-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071017
application number: ANDA071017
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSun Pharmaceutical Industries, Inc.4833319a-a7b3-4bf4-bec4-6531b43182d42025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071017
application number: ANDA071017
ndc (package): 53489-146-05
ndc (product): 53489-146
ndc11 (package): 53489014605

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN4833319a-a7b3-4bf4-bec4-6531b43182d419
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN4833319a-a7b3-4bf4-bec4-6531b43182d419
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD4833319a-a7b3-4bf4-bec4-6531b43182d419
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD4833319a-a7b3-4bf4-bec4-6531b43182d419
198334SMX 400 MG / TMP 80 MG Oral TabletSY4833319a-a7b3-4bf4-bec4-6531b43182d419
198335SMX 800 MG / TMP 160 MG Oral TabletSY4833319a-a7b3-4bf4-bec4-6531b43182d419
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSNbd3161fe-23d7-458a-86a4-fb958d9c94d312
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNbd3161fe-23d7-458a-86a4-fb958d9c94d312
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCDbd3161fe-23d7-458a-86a4-fb958d9c94d312
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDbd3161fe-23d7-458a-86a4-fb958d9c94d312
198334SMX 400 MG / TMP 80 MG Oral TabletSYbd3161fe-23d7-458a-86a4-fb958d9c94d312
198335SMX 800 MG / TMP 160 MG Oral TabletSYbd3161fe-23d7-458a-86a4-fb958d9c94d312
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN4196e73b-5aec-2ede-e054-00144ff8d46c5
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD4196e73b-5aec-2ede-e054-00144ff8d46c5
198335SMX 800 MG / TMP 160 MG Oral TabletSY4196e73b-5aec-2ede-e054-00144ff8d46c5
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3fcdd0a5-23e1-49c5-b9a7-f2c000cad1b23
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNd48ed3f0-d1dc-4548-95df-7786ce0f444a3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN6d829c49-4cc2-411f-aa13-67e20e30ebf43
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3fcdd0a5-23e1-49c5-b9a7-f2c000cad1b23
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDd48ed3f0-d1dc-4548-95df-7786ce0f444a3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD6d829c49-4cc2-411f-aa13-67e20e30ebf43
198335SMX 800 MG / TMP 160 MG Oral TabletSY3fcdd0a5-23e1-49c5-b9a7-f2c000cad1b23
198335SMX 800 MG / TMP 160 MG Oral TabletSYd48ed3f0-d1dc-4548-95df-7786ce0f444a3
198335SMX 800 MG / TMP 160 MG Oral TabletSY6d829c49-4cc2-411f-aa13-67e20e30ebf43
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN49075f3d-eb10-464b-8ab9-5fad63246fbf2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN1fbbc3e5-ddc6-1e87-e054-00144ff8d46c2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD49075f3d-eb10-464b-8ab9-5fad63246fbf2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD1fbbc3e5-ddc6-1e87-e054-00144ff8d46c2
198335SMX 800 MG / TMP 160 MG Oral TabletSY49075f3d-eb10-464b-8ab9-5fad63246fbf2
198335SMX 800 MG / TMP 160 MG Oral TabletSY1fbbc3e5-ddc6-1e87-e054-00144ff8d46c2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNc996a6d3-fa66-4c84-bf0a-236b5001fb601
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN09f328ce-31d6-480f-88a6-846ac66fddbe1
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDc996a6d3-fa66-4c84-bf0a-236b5001fb601
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD09f328ce-31d6-480f-88a6-846ac66fddbe1
198335SMX 800 MG / TMP 160 MG Oral TabletSY09f328ce-31d6-480f-88a6-846ac66fddbe1
198335SMX 800 MG / TMP 160 MG Oral TabletSYc996a6d3-fa66-4c84-bf0a-236b5001fb601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-146-0553489014605500 TABLET in 1 BOTTLE, PLASTIC (53489-146-05) 500 tablet1986-08-250000-00-00NoNoCurrent