SULFATRIM

Product NDC
67296-1163
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

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

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
67296-1163-167296116301100 mL in 1 BOTTLE (67296-1163-1) 100 ml1983-07-010000-00-00NoNoCurrent
67296-1163-267296116302200 mL in 1 BOTTLE (67296-1163-2) 200 ml1983-07-010000-00-00NoNoCurrent