SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product NDC
61919-144
Requested package NDC
61919-144-30
11-digit product format
619190144
Labeler code
61919
Product ID
61919-144_9cad4b05-2b58-d662-e053-2995a90ad7fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090624
Marketing category
ANDA
Marketing start
2019-08-13
Marketing end
0000-00-00
Substance
TRIMETHOPRIM; SULFAMETHOXAZOLE
Active strength
160 mg/1; mg/1
Pharmacologic classes
Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage61919-14461919-144-30IInactivated by FDA2026-08-03

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 · 18 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
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 · 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 UTC2026-02A090624-001SULFAMETHOXAZOLE 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…
2022-03-09 01:35 UTC2022-03A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090624-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-02-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A090624-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-02-16782e0a99824c…

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 UTC2026-02A090624-001AB1011fe1cb6892…
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…
2022-03-09 01:35 UTC2022-03A090624-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090624-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090624-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090624-002AB1782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-144-20SULFAMETHOXAZOLE AND TRIMETHOPRIM20 in 1 BOTTLETABLET202
61919-144-30SULFAMETHOXAZOLE AND TRIMETHOPRIM30 in 1 BOTTLETABLET302
61919-144-56SULFAMETHOXAZOLE AND TRIMETHOPRIM56 in 1 BOTTLETABLET562
61919-144-06SULFAMETHOXAZOLE AND TRIMETHOPRIM6 in 1 BOTTLETABLET61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-144-06EA - Each61919-144d0a4d718-0cb8-4e70-8a8a-d69dd775ac5512019-09-05
61919-144-20EA - Each61919-144a3d7397d-7360-4279-a934-9403a7c1b2d112019-04-11
61919-144-30EA - Each61919-144e6f62f97-511b-462d-8ab2-bcd6b406a2e112019-09-05
61919-144-56EA - Each61919-1440cd46a85-ebbe-43f7-947b-9b51444d0c3d12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-144SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]2Legacy NDC, 2 package rows20180615_5488e98e-3955-017c-e054-00144ff8d46c.zip
61919-144SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20200122_9003c06e-5d28-af7e-e053-2995a90ad432.zip
61919-144SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190814_9003519f-26d6-5d4c-e053-2995a90a429e.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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.c45ac3a4-d397-486e-abd1-3499165430682026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCardinal Health 107, LLC08500fcb-dbec-4ac2-91c3-189d27907ec02026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMUnit Dose Solutions, Inc.562e2547-db2d-e2d2-e063-6294a90a1f5d2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSt. Mary's Medical Park Pharmacye3a49508-0ebe-1334-e053-2a95a90ae1732026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCoupler LLC518cc045-a12b-f08f-e063-6394a90acb0c2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.ce44959b-4bfe-4ba9-9fc2-7f9d4663d5422026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAvPAK29df8839-3dfa-0b2b-c5a3-906db6997b3b2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions75b9d194-b960-4943-bedc-96e3d65c4da92026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.7f82e5e0-b627-a3f3-e053-2991aa0abaa52026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSportpharm LLC52304e5e-d097-48f2-8b64-210908e4eb542026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.99e1ace6-7665-4f87-82fd-5e7c4989e0982026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.ec2e335c-3357-40d8-9615-a09fc40ce5f42026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfameth/Trimeth-DSSULFAMETH/TRIMETH-DSDirect_Rx90026ce8-3305-6272-e053-2995a90a57e02026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.8c3e4738-0e0a-a854-e053-2995a90a7d712026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLCf7f97520-d063-ec87-e053-6294a90aae0c2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLC471c5995-a4df-fbe3-e063-6394a90aa50e2025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMQPharma, Inc.41529314-b203-47f4-88dd-5aa57c74985f2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMVERITYRX, LLC427b8040-99a4-8e81-e063-6394a90a76c52025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.1274cefb-0799-e2e4-e063-6394a90aad022025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090624
application number: ANDA090624
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPreferred Pharmaceuticals Inc.d60c218c-6529-4944-af0b-a9dc720f32e92025-09-24Warnings, 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 TabletPSN5488e98e-3955-017c-e054-00144ff8d46c2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN9003c06e-5d28-af7e-e053-2995a90ad4322
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD5488e98e-3955-017c-e054-00144ff8d46c2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD9003c06e-5d28-af7e-e053-2995a90ad4322
198335SMX 800 MG / TMP 160 MG Oral TabletSY5488e98e-3955-017c-e054-00144ff8d46c2
198335SMX 800 MG / TMP 160 MG Oral TabletSY9003c06e-5d28-af7e-e053-2995a90ad4322
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN9003519f-26d6-5d4c-e053-2995a90a429e1
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD9003519f-26d6-5d4c-e053-2995a90a429e1
198335SMX 800 MG / TMP 160 MG Oral TabletSY9003519f-26d6-5d4c-e053-2995a90a429e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-144-306191901443030 TABLET in 1 BOTTLE (61919-144-30) 30 tablet2019-08-130000-00-00NoNoCurrent