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

Additional Listing Data#

Finished product
Yes
Brand name base
SULFATRIM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE200 mg/5mL
TRIMETHOPRIM40 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui208406, 313134

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
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