SULFATRIM

Product NDC
67296-1163
Requested package NDC
67296-1163-2
11-digit product format
672961163
Labeler code
67296
Product ID
67296-1163_9c9eebfb-bf40-1282-e053-2995a90a3197
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFATRIM
Dosage form
SUSPENSION
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA018615
Marketing category
NDA
Marketing start
1983-07-01
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200 mg/5mL; mg/5mL
Pharmacologic classes
Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 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 packagepackage67296-116367296-1163-2IInactivated by FDA2026-08-10

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 · 19 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
N018615-001SULFATRIM PEDIATRICSULFAMETHOXAZOLE; TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07
N018615-002SULFATRIMSULFAMETHOXAZOLE; TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018615-001AB

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 UTC2026-02N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07782e0a99824c…
2021-12-28 21:50 UTC2021-12N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018615-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018615-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018615-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018615-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018615-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018615-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018615-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018615-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018615-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018615-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018615-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018615-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018615-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018615-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018615-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018615-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018615-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018615-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018615-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018615-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018615-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018615-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018615-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018615-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018615-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018615-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018615-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018615-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018615-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018615-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018615-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018615-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018615-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018615-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018615-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018615-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018615-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018615-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018615-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018615-001AB1cb3db0bc1861…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1163-12022-01-28C16284748780-1d6a99b39-9fab-a426-e053-dadaa90af4c24eb8dbf3-616c-0bbf-e054-00144ff88e88
67296-1163-22022-01-28C16284748780-1d6a99b39-9fab-a426-e053-dadaa90af4c24eb8dbf3-616c-0bbf-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1163-1SULFATRIM100 mL in 1 BOTTLESUSPENSION1002
67296-1163-2SULFATRIM200 mL in 1 BOTTLESUSPENSION2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1163SULFATRIM SUSPENSION [REDPHARM DRUG, INC.]2Legacy NDC, 2 package rows20200121_4eb8dbf3-616c-0bbf-e054-00144ff88e88.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions80f7f00b-add4-4d6b-9e9c-bea29768c2392026-01-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 018615
application number: NDA018615
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMPAI Holdings, LLC dba PAI Pharmac62086ea-ba15-40f5-8431-4639c60c98252025-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 018615
application number: NDA018615
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMPreferred Pharmaceuticals, Inc.cd4932ce-0856-4e99-8baf-70afce1d7ffd2025-01-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 018615
application number: NDA018615
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPAI Holdings, LLC dba PAI Pharma777da85a-a776-4681-976d-326ec421cfc92024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018615
application number: NDA018615

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN4eb8dbf3-616c-0bbf-e054-00144ff88e882
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD4eb8dbf3-616c-0bbf-e054-00144ff88e882
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY4eb8dbf3-616c-0bbf-e054-00144ff88e882
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY4eb8dbf3-616c-0bbf-e054-00144ff88e882
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY4eb8dbf3-616c-0bbf-e054-00144ff88e882
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY4eb8dbf3-616c-0bbf-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1163-267296116302200 mL in 1 BOTTLE (67296-1163-2) 200 ml1983-07-010000-00-00NoNoCurrent