FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
51655-188
11-digit product format
516550188
Labeler code
51655
Product ID
51655-188_49743d69-d423-5485-e063-6394a90ab240
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090624
Marketing category
ANDA
Marketing start
2023-03-23
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
51655-188-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET204
51655-188-53Sulfamethoxazole and Trimethoprim10 in 1 BOTTLE, PLASTICTABLET104
51655-188-84Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET144
51655-188-87Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-188SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 4 package rows20241215_f7f97520-d063-ec87-e053-6294a90aae0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNf7f97520-d063-ec87-e053-6294a90aae0c4
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDf7f97520-d063-ec87-e053-6294a90aae0c4
198335SMX 800 MG / TMP 160 MG Oral TabletSYf7f97520-d063-ec87-e053-6294a90aae0c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-188-205165501882020 TABLET in 1 BOTTLE, PLASTIC (51655-188-20) 20 tablet2023-03-23NoNoCurrent
51655-188-535165501885310 TABLET in 1 BOTTLE, PLASTIC (51655-188-53) 10 tablet2023-04-03NoNoCurrent
51655-188-845165501888414 TABLET in 1 BOTTLE, PLASTIC (51655-188-84) 14 tablet2023-03-23NoNoCurrent
51655-188-87516550188876 TABLET in 1 BOTTLE, PLASTIC (51655-188-87) 6 tablet2023-03-23NoNoCurrent