FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
43353-368
11-digit product format
433530368
Labeler code
43353
Product ID
43353-368_1242512b-c6e2-466f-a829-aed0a76785da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078060
Marketing category
ANDA
Marketing start
2007-01-25
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 mg/1; mg/1
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
2019-12-31
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-368-142020-01-31C16284748780-19d75b9d0-7bf4-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP, 800 mg/160 mg (DOUBLE STRENGTH) AND 400 mg/80 mg
43353-368-202020-01-31C16284748780-19d75b9d0-7bf4-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP, 800 mg/160 mg (DOUBLE STRENGTH) AND 400 mg/80 mg
43353-368-302020-01-31C16284748780-19d75b9d0-7bf4-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP, 800 mg/160 mg (DOUBLE STRENGTH) AND 400 mg/80 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-368-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET141
43353-368-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET201
43353-368-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-368SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20140521_0ea2991b-03c4-4fb6-a9d6-341779d92ad9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN0ea2991b-03c4-4fb6-a9d6-341779d92ad91
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD0ea2991b-03c4-4fb6-a9d6-341779d92ad91
198335SMX 800 MG / TMP 160 MG Oral TabletSY0ea2991b-03c4-4fb6-a9d6-341779d92ad91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-368-144335303681414 in 1 BOTTLE, PLASTICHistorical
43353-368-204335303682020 in 1 BOTTLE, PLASTICHistorical
43353-368-304335303683030 in 1 BOTTLE, PLASTICHistorical