FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
60760-541
11-digit product format
607600541
Labeler code
60760
Product ID
60760-541_48edf3cc-9d7f-d5eb-e063-6394a90a76d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA090624
Marketing category
ANDA
Marketing start
2022-06-22
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
60760-541-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET64
60760-541-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET144
60760-541-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-541-06EA - Each60760-5416d8faf16-9950-4674-9c89-ad1eec98d68112023-03-13
60760-541-14EA - Each60760-541374aa243-0694-4794-a06f-a83c13902b6f12022-11-07
60760-541-20EA - Each60760-54101c91e01-f50b-4a21-9bfd-2e4c7df319e712022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-541SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [ST. MARY'S MEDICAL PARK PHARMACY]3Current NDC, Legacy NDC, 3 package rows20230124_e3a49508-0ebe-1334-e053-2a95a90ae173.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNe3a49508-0ebe-1334-e053-2a95a90ae1734
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDe3a49508-0ebe-1334-e053-2a95a90ae1734
198335SMX 800 MG / TMP 160 MG Oral TabletSYe3a49508-0ebe-1334-e053-2a95a90ae1734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-541-06607600541066 TABLET in 1 BOTTLE, PLASTIC (60760-541-06) 6 tablet2023-01-17NoNoCurrent
60760-541-146076005411414 TABLET in 1 BOTTLE, PLASTIC (60760-541-14) 14 tablet2022-08-180000-00-00NoNoCurrent
60760-541-206076005412020 TABLET in 1 BOTTLE, PLASTIC (60760-541-20) 20 tablet2022-06-220000-00-00NoNoCurrent