FDA.reportPublic FDA data

SULFATRIM

Product NDC
17856-0007
11-digit product format
178560007
Labeler code
17856
Product ID
17856-0007_e72be307-9cf4-4f42-8a2a-ae84e625b60e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Atlantic Biologicals Corps
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
17856-0007-12020-01-31C16284748780-19d75b9d1-1167-f424-e053-dadaa90a57ceSULFATRIM TM (Sulfamethoxazole and Trimethoprim Oral Suspension, USP)
17856-0007-22020-01-31C16284748780-19d75b9d1-1167-f424-e053-dadaa90a57ceSULFATRIM TM (Sulfamethoxazole and Trimethoprim Oral Suspension, USP)
17856-0007-52020-01-31C16284748780-19d75b9d1-1167-f424-e053-dadaa90a57ceSULFATRIM TM (Sulfamethoxazole and Trimethoprim Oral Suspension, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0007-1SULFATRIM10 mL in 1 CUPSUSPENSION104
17856-0007-1SULFATRIM72 in 1 BOXSUSPENSION724
17856-0007-2SULFATRIM20 mL in 1 CUPSUSPENSION204
17856-0007-5SULFATRIM5 mL in 1 CUPSUSPENSION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0007SULFATRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]4Legacy NDC, 4 package rows20161130_943ea381-7902-4ce9-abad-4270ebde9d3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN943ea381-7902-4ce9-abad-4270ebde9d3c4
208406SULFATRIM 200 MG / 40 MG in 5 mL Oral SuspensionPSN943ea381-7902-4ce9-abad-4270ebde9d3c4
208406sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]SBD943ea381-7902-4ce9-abad-4270ebde9d3c4
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD943ea381-7902-4ce9-abad-4270ebde9d3c4
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY943ea381-7902-4ce9-abad-4270ebde9d3c4
208406SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]SY943ea381-7902-4ce9-abad-4270ebde9d3c4
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY943ea381-7902-4ce9-abad-4270ebde9d3c4
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY943ea381-7902-4ce9-abad-4270ebde9d3c4
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY943ea381-7902-4ce9-abad-4270ebde9d3c4
208406Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral SuspensionSY943ea381-7902-4ce9-abad-4270ebde9d3c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0007-11785600070110 mL in 1 CUP10 mlHistorical
17856-0007-21785600070220 mL in 1 CUP20 mlHistorical
17856-0007-5178560007055 mL in 1 CUP5 mlHistorical