FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
70518-0863
11-digit product format
705180863
Labeler code
70518
Product ID
70518-0863_4845e0d2-b124-3702-e063-6394a90ae1e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2017-11-24
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0863-0Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET2021
70518-0863-1Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET621
70518-0863-2Sulfamethoxazole and Trimethoprim100 in 1 BOXTABLET10021
70518-0863-3Sulfamethoxazole and Trimethoprim1 in 1 POUCHTABLET121
70518-0863-4Sulfamethoxazole and Trimethoprim20 in 1 BLISTER PACKTABLET2021
70518-0863-5Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET1421
70518-0863-6Sulfamethoxazole and Trimethoprim30 in 1 BLISTER PACKTABLET3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0863SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 7 package rows20250115_99e1ace6-7665-4f87-82fd-5e7c4989e098.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN99e1ace6-7665-4f87-82fd-5e7c4989e09821
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD99e1ace6-7665-4f87-82fd-5e7c4989e09821
198335SMX 800 MG / TMP 160 MG Oral TabletSY99e1ace6-7665-4f87-82fd-5e7c4989e09821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0863-07051808630020 in 1 BOTTLE, PLASTICHistorical
70518-0863-1705180863016 in 1 BOTTLE, PLASTICHistorical
70518-0863-270518086302100 POUCH in 1 BOX (70518-0863-2) > 1 TABLET in 1 POUCH (70518-0863-3) 100 pouch2021-10-120000-00-00NoNoCurrent
70518-0863-3705180863031 in 1 POUCHHistorical
70518-0863-47051808630420 TABLET in 1 BLISTER PACK (70518-0863-4) 20 tablet2021-11-190000-00-00NoNoCurrent
70518-0863-57051808630514 TABLET in 1 BOTTLE, PLASTIC (70518-0863-5) 14 tablet2023-04-11NoNoHistorical
70518-0863-67051808630630 TABLET in 1 BLISTER PACK (70518-0863-6) 30 tablet2025-06-25NoNoHistorical