FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
70934-043
11-digit product format
709340043
Labeler code
70934
Product ID
70934-043_b8a25789-6417-58b0-e053-2995a90a8167
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA071017
Marketing category
ANDA
Marketing start
2017-10-30
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
2022-12-31
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
70934-043-062023-01-30C16284748780-1f386c64a-2984-0266-e053-dadaa90a7c1aSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP
70934-043-072023-01-30C16284748780-1f386c64a-2984-0266-e053-dadaa90a7c1aSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP
70934-043-102023-01-30C16284748780-1f386c64a-2984-0266-e053-dadaa90a7c1aSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP
70934-043-122023-01-30C16284748780-1f386c64a-2984-0266-e053-dadaa90a7c1aSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP
70934-043-142023-01-30C16284748780-1f386c64a-2984-0266-e053-dadaa90a7c1aSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP
70934-043-202023-01-30C16284748780-1f386c64a-2984-0266-e053-dadaa90a7c1aSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP
70934-043-282023-01-30C16284748780-1f386c64a-2984-0266-e053-dadaa90a7c1aSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-043-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET63
70934-043-07Sulfamethoxazole and Trimethoprim7 in 1 BOTTLE, PLASTICTABLET73
70934-043-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLE, PLASTICTABLET103
70934-043-12Sulfamethoxazole and Trimethoprim12 in 1 BOTTLE, PLASTICTABLET123
70934-043-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET143
70934-043-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET203
70934-043-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLE, PLASTICTABLET283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-043-06EA - Each70934-043deea131b-9061-49c9-9c6a-344831bca75212018-01-12
70934-043-12EA - Each70934-043c0ec9119-2e63-4ab7-a8e2-9948a5d6fac712018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-043SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 7 package rows20210112_6d829c49-4cc2-411f-aa13-67e20e30ebf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN6d829c49-4cc2-411f-aa13-67e20e30ebf43
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD6d829c49-4cc2-411f-aa13-67e20e30ebf43
198335SMX 800 MG / TMP 160 MG Oral TabletSY6d829c49-4cc2-411f-aa13-67e20e30ebf43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-043-06709340043066 TABLET in 1 BOTTLE, PLASTIC (70934-043-06) 6 tablet2017-10-300000-00-00NoNoCurrent
70934-043-07709340043077 TABLET in 1 BOTTLE, PLASTIC (70934-043-07) 7 tablet2017-10-300000-00-00NoNoCurrent
70934-043-107093400431010 TABLET in 1 BOTTLE, PLASTIC (70934-043-10) 10 tablet2017-10-300000-00-00NoNoCurrent
70934-043-127093400431212 TABLET in 1 BOTTLE, PLASTIC (70934-043-12) 12 tablet2017-10-300000-00-00NoNoCurrent
70934-043-147093400431414 TABLET in 1 BOTTLE, PLASTIC (70934-043-14) 14 tablet2017-10-300000-00-00NoNoCurrent
70934-043-207093400432020 TABLET in 1 BOTTLE, PLASTIC (70934-043-20) 20 tablet2017-10-300000-00-00NoNoCurrent
70934-043-287093400432828 TABLET in 1 BOTTLE, PLASTIC (70934-043-28) 28 tablet2017-10-300000-00-00NoNoCurrent