FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
82982-044
11-digit product format
829820044
Labeler code
82982
Product ID
82982-044_198ccc85-82fd-0a2b-e063-6394a90a249f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Pharmasource Meds, LLC
Application
ANDA090624
Marketing category
ANDA
Marketing start
2023-02-28
Marketing end
2027-11-30
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800; 160 mg/1; mg/1
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE800 mg/1
TRIMETHOPRIM160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui198335

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82982-044-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET142
82982-044-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82982-044SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PHARMASOURCE MEDS, LLC]2Current NDC, 2 package rows20240601_f564a029-4b20-301a-e053-2995a90adcc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNf564a029-4b20-301a-e053-2995a90adcc02
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDf564a029-4b20-301a-e053-2995a90adcc02
198335SMX 800 MG / TMP 160 MG Oral TabletSYf564a029-4b20-301a-e053-2995a90adcc02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82982-044-148298200441414 TABLET in 1 BOTTLE (82982-044-14) 14 tablet2023-02-282027-11-30NoNoHistorical
82982-044-208298200442020 TABLET in 1 BOTTLE (82982-044-20) 20 tablet2023-02-282027-10-31NoNoHistorical