FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
76420-064
11-digit product format
764200064
Labeler code
76420
Product ID
76420-064_ae77a5c0-a27b-770c-e053-2a95a90a6a96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
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
76420-064-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET62
76420-064-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET102
76420-064-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET142
76420-064-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET202
76420-064-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET282
76420-064-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-064-06EA - Each76420-064c9234cf6-a38e-4b80-a8f3-d3d4c630f03712022-05-04
76420-064-14EA - Each76420-064993785aa-cc6e-4f62-abea-623dc6e82d7f12022-05-04
76420-064-20EA - Each76420-064e3e4d2d4-6a41-4dc4-98a3-60cdc386624312022-05-04
76420-064-28EA - Each76420-064c075f2cb-bcb1-43f6-a605-37ef67a1586b12022-05-04
76420-064-30EA - Each76420-064a35c9d1f-b284-4120-afad-26aca635488b12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-064SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 6 package rows20200905_e6c0f80a-ba22-4690-aaf8-48a4602b6831.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNe6c0f80a-ba22-4690-aaf8-48a4602b68312
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDe6c0f80a-ba22-4690-aaf8-48a4602b68312
198335SMX 800 MG / TMP 160 MG Oral TabletSYe6c0f80a-ba22-4690-aaf8-48a4602b68312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-064-06764200064066 TABLET in 1 BOTTLE (76420-064-06) 6 tablet2020-09-040000-00-00NoNoCurrent
76420-064-107642000641010 TABLET in 1 BOTTLE (76420-064-10) 10 tablet2020-09-040000-00-00NoNoCurrent
76420-064-147642000641414 TABLET in 1 BOTTLE (76420-064-14) 14 tablet2020-02-110000-00-00NoNoCurrent
76420-064-207642000642020 TABLET in 1 BOTTLE (76420-064-20) 20 tablet2020-02-110000-00-00NoNoCurrent
76420-064-287642000642828 TABLET in 1 BOTTLE (76420-064-28) 28 tablet2020-02-110000-00-00NoNoCurrent
76420-064-307642000643030 TABLET in 1 BOTTLE (76420-064-30) 30 tablet2020-09-040000-00-00NoNoCurrent