FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
65162-271
11-digit product format
651620271
Labeler code
65162
Product ID
65162-271_fd58f01a-3607-4f18-97e3-f695bcb32ad5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-02-25
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
400; 80 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
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE400 mg/1
TRIMETHOPRIM80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAN164J8Y0X, JE42381TNV
Rxcui198334, 198335

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
65162-271-05Sulfamethoxazole and Trimethoprim50 in 1 BOTTLETABLET5012
65162-271-10Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET10012
65162-271-11Sulfamethoxazole and Trimethoprim1000 in 1 BOTTLETABLET100012
65162-271-50Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-271-10EA - Each65162-271dd88f24f-1d66-498a-9eef-45dd7a77d1bf12019-11-12
65162-271-50EA - Each65162-271d9038452-3b0a-4591-9478-2750ede7df4212019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-271SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS LLC]10Current NDC, Legacy NDC, 4 package rows20241122_f0e73842-6002-43c2-97fc-0cadc1bf6346.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSNf0e73842-6002-43c2-97fc-0cadc1bf634612
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNf0e73842-6002-43c2-97fc-0cadc1bf634612
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCDf0e73842-6002-43c2-97fc-0cadc1bf634612
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDf0e73842-6002-43c2-97fc-0cadc1bf634612
198334SMX 400 MG / TMP 80 MG Oral TabletSYf0e73842-6002-43c2-97fc-0cadc1bf634612
198335SMX 800 MG / TMP 160 MG Oral TabletSYf0e73842-6002-43c2-97fc-0cadc1bf634612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-271-056516202710550 TABLET in 1 BOTTLE (65162-271-05) 50 tablet2010-02-250000-00-00NoNoCurrent
65162-271-1065162027110100 TABLET in 1 BOTTLE (65162-271-10) 100 tablet2010-02-250000-00-00NoNoCurrent
65162-271-11651620271111000 TABLET in 1 BOTTLE (65162-271-11) 1000 tablet2010-02-250000-00-00NoNoCurrent
65162-271-5065162027150500 TABLET in 1 BOTTLE (65162-271-50) 500 tablet2010-02-250000-00-00NoNoCurrent