FDA.reportPublic FDA data

SULFATRIM

Product NDC
67296-1657
11-digit product format
672961657
Labeler code
67296
Product ID
67296-1657_1dfcbde9-641f-7454-e063-6394a90ad1e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA018615
Marketing category
NDA
Marketing start
1983-07-01
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200; 40 mg/5mL; mg/5mL
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1657IInactivated by FDA2026-08-03
excluded packagepackage67296-165767296-1657-1IInactivated by FDA2026-08-03
excluded packagepackage67296-165767296-1657-2IInactivated by FDA2026-08-03

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07a50c72e98297…
2026-08-01 22:54:322026-06N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N018615-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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
67296-1657-12024-07-24C16284748780-11030e365-48e4-111a-e063-dadaa90a10e2SULFATRIM™ - sulfamethoxazole and trimethoprim suspension
67296-1657-22024-07-24C16284748780-11030e365-48e4-111a-e063-dadaa90a10e2SULFATRIM™ - sulfamethoxazole and trimethoprim suspension
67296-1657-12024-01-30C16284748780-11030e365-48e4-111a-e063-dadaa90a10e2SULFATRIM™ - sulfamethoxazole and trimethoprim suspension
67296-1657-22024-01-30C16284748780-11030e365-48e4-111a-e063-dadaa90a10e2SULFATRIM™ - sulfamethoxazole and trimethoprim suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1657-1SULFATRIM100 mL in 1 BOTTLESUSPENSION1003
67296-1657-2SULFATRIM200 mL in 1 BOTTLESUSPENSION2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1657SULFATRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) SUSPENSION [REDPHARM DRUG, INC.]3Current NDC, Legacy NDC, 2 package rows20240725_b339af0b-4fa2-e8c3-e053-2995a90a6a34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406SULFATRIM 200 MG / 40 MG in 5 mL Oral SuspensionPSNb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]SBDb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]SYb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1657-167296165701100 mL in 1 BOTTLE (67296-1657-1) 100 ml1983-07-010000-00-00NoNoCurrent
67296-1657-267296165702200 mL in 1 BOTTLE (67296-1657-2) 200 ml1983-07-010000-00-00NoNoCurrent