FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
51655-307
11-digit product format
516550307
Labeler code
51655
Product ID
51655-307_49044499-64e8-96bd-e063-6294a90a4515
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076899
Marketing category
ANDA
Marketing start
2022-11-17
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
51655-307-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET203
51655-307-29Sulfamethoxazole and Trimethoprim28 in 1 BOTTLE, PLASTICTABLET283
51655-307-53Sulfamethoxazole and Trimethoprim10 in 1 BOTTLE, PLASTICTABLET103
51655-307-84Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET143
51655-307-87Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-307SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 5 package rows20240718_f2b8e9d9-1274-22ca-e053-2a95a90a6f1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNf2b8e9d9-1274-22ca-e053-2a95a90a6f1a3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDf2b8e9d9-1274-22ca-e053-2a95a90a6f1a3
198335SMX 800 MG / TMP 160 MG Oral TabletSYf2b8e9d9-1274-22ca-e053-2a95a90a6f1a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-307-205165503072020 TABLET in 1 BOTTLE, PLASTIC (51655-307-20) 20 tablet2022-11-17NoNoHistorical
51655-307-295165503072928 TABLET in 1 BOTTLE, PLASTIC (51655-307-29) 28 tablet2023-02-03NoNoHistorical
51655-307-535165503075310 TABLET in 1 BOTTLE, PLASTIC (51655-307-53) 10 tablet2023-01-02NoNoHistorical
51655-307-845165503078414 TABLET in 1 BOTTLE, PLASTIC (51655-307-84) 14 tablet2022-11-17NoNoHistorical
51655-307-87516550307876 TABLET in 1 BOTTLE, PLASTIC (51655-307-87) 6 tablet2023-01-12NoNoHistorical