FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
68788-7622
11-digit product format
687887622
Labeler code
68788
Product ID
68788-7622_bc3be94a-c7ef-4a61-8713-c89b25e04164
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2020-02-14
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Listing expiration
2026-12-31

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
68788-7622-1Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET106
68788-7622-2Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET206
68788-7622-3Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET306
68788-7622-4Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET146
68788-7622-6Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET66
68788-7622-7Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET286
68788-7622-8Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET406

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7622-1EA - Each68788-7622680263f3-b67c-4220-ae1b-0a6796da6d8912020-04-20
68788-7622-2EA - Each68788-7622ed139f62-b0de-476e-bf64-8fa130a360d212020-04-20
68788-7622-3EA - Each68788-7622b1369d1c-06e8-4c60-aff4-619970b16e4512020-04-20
68788-7622-4EA - Each68788-7622ce48a66c-8b46-453d-95e2-49792402f8f312020-04-20
68788-7622-6EA - Each68788-7622baa1908a-417a-4664-8c66-cdc8381f200212020-04-20
68788-7622-7EA - Each68788-7622a6145f4c-848f-4319-a05f-33d527966c1712020-04-20
68788-7622-8EA - Each68788-762297d7209e-2029-468a-ab00-9f63d04926d912020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7622SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 7 package rows20240816_d60c218c-6529-4944-af0b-a9dc720f32e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNd60c218c-6529-4944-af0b-a9dc720f32e96
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDd60c218c-6529-4944-af0b-a9dc720f32e96
198335SMX 800 MG / TMP 160 MG Oral TabletSYd60c218c-6529-4944-af0b-a9dc720f32e96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7622-16878876220110 TABLET in 1 BOTTLE (68788-7622-1) 10 tablet2020-02-140000-00-00NoNoCurrent
68788-7622-26878876220220 TABLET in 1 BOTTLE (68788-7622-2) 20 tablet2020-02-140000-00-00NoNoCurrent
68788-7622-36878876220330 TABLET in 1 BOTTLE (68788-7622-3) 30 tablet2020-02-140000-00-00NoNoCurrent
68788-7622-46878876220414 TABLET in 1 BOTTLE (68788-7622-4) 14 tablet2020-02-140000-00-00NoNoCurrent
68788-7622-6687887622066 TABLET in 1 BOTTLE (68788-7622-6) 6 tablet2020-02-140000-00-00NoNoCurrent
68788-7622-76878876220728 TABLET in 1 BOTTLE (68788-7622-7) 28 tablet2020-02-140000-00-00NoNoCurrent
68788-7622-86878876220840 TABLET in 1 BOTTLE (68788-7622-8) 40 tablet2020-02-140000-00-00NoNoCurrent