Sulfamethoxazole and Trimethoprim

Product NDC
42291-759
11-digit product format
422910759
Labeler code
42291
Product ID
42291-759_4a7ee07f-6eea-dd30-e063-6394a90adac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA076899
Marketing category
ANDA
Marketing start
2015-08-05
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
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42291-75942291-759-12DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
2027-12-31

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 · 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
9f130443-c8e7-9122-8f27-f72f07f3f29eAvailable 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
42291-759-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET10012
42291-759-12Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET2012
42291-759-50Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-759-01EA - Each42291-7593c013c94-cb61-4b4d-b48d-4a4d749fe1cb12016-12-07
42291-759-12EA - Each42291-759597888fa-2166-4b59-91bf-f9b1aaa8d1dd12016-12-07
42291-759-50EA - Each42291-759b93552e0-e949-457b-be09-af982831ef1912015-09-10

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-759SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVKARE]10Current NDC, Legacy NDC, 3 package rows20240111_9f130443-c8e7-9122-8f27-f72f07f3f29e.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
ndc (product): 42291-759
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
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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-759-0142291075901100 TABLET in 1 BOTTLE (42291-759-01) 100 tablet2016-10-310000-00-00NoNoCurrent
42291-759-124229107591220 TABLET in 1 BOTTLE (42291-759-12) 20 tablet2016-10-310000-00-00NoNoCurrent
42291-759-5042291075950500 TABLET in 1 BOTTLE (42291-759-50) 500 tablet2015-08-050000-00-00NoNoCurrent