FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
68071-4710
11-digit product format
680714710
Labeler code
68071
Product ID
68071-4710_4a683588-fca7-6f57-e063-6394a90a08c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4710-12024-06-12C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-22024-06-12C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-32024-06-12C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-42024-06-12C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-52024-06-12C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-62024-06-12C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-82024-06-12C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-12023-01-30C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-22023-01-30C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-32023-01-30C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-42023-01-30C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-52023-01-30C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-62023-01-30C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-82023-01-30C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-42021-02-17C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4710-42021-01-29C16284748780-1ba0f9c33-2551-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4710-1Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET106
68071-4710-2Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET206
68071-4710-3Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET306
68071-4710-4Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET146
68071-4710-5Sulfamethoxazole and Trimethoprim15 in 1 BOTTLETABLET156
68071-4710-6Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET66
68071-4710-8Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4710SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 7 package rows20240614_7f82e5e0-b627-a3f3-e053-2991aa0abaa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN7f82e5e0-b627-a3f3-e053-2991aa0abaa56
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD7f82e5e0-b627-a3f3-e053-2991aa0abaa56
198335SMX 800 MG / TMP 160 MG Oral TabletSY7f82e5e0-b627-a3f3-e053-2991aa0abaa56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4710-16807147100110 TABLET in 1 BOTTLE (68071-4710-1) 10 tablet2019-01-150000-00-00NoNoCurrent
68071-4710-26807147100220 TABLET in 1 BOTTLE (68071-4710-2) 20 tablet2019-01-150000-00-00NoNoCurrent
68071-4710-36807147100330 TABLET in 1 BOTTLE (68071-4710-3) 30 tablet2019-01-150000-00-00NoNoCurrent
68071-4710-46807147100414 TABLET in 1 BOTTLE (68071-4710-4) 14 tablet2019-01-150000-00-00NoNoCurrent
68071-4710-56807147100515 TABLET in 1 BOTTLE (68071-4710-5) 15 tablet2019-01-150000-00-00NoNoCurrent
68071-4710-6680714710066 TABLET in 1 BOTTLE (68071-4710-6) 6 tablet2019-01-150000-00-00NoNoCurrent
68071-4710-86807147100828 TABLET in 1 BOTTLE (68071-4710-8) 28 tablet2019-01-150000-00-00NoNoCurrent