FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
63629-1765
11-digit product format
636291765
Labeler code
63629
Product ID
63629-1765_a903d079-327d-475b-953f-045f458657e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-09-13
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-1765-02020-10-16C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-12020-10-16C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-22020-10-16C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-32020-10-16C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-42020-10-16C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-52020-10-16C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-62020-10-16C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-72020-10-16C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-82020-10-16C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-92020-10-16C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-02020-01-31C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-12020-01-31C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-22020-01-31C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-32020-01-31C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-42020-01-31C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-52020-01-31C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-62020-01-31C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-72020-01-31C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-82020-01-31C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
63629-1765-92020-01-31C16284748780-19d75b9d0-4336-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1765-0Sulfamethoxazole and Trimethoprim21 in 1 BOTTLETABLET2123
63629-1765-1Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET2023
63629-1765-2Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET1423
63629-1765-3Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET1023
63629-1765-4Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET2823
63629-1765-5Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET4023
63629-1765-6Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET623
63629-1765-7Sulfamethoxazole and Trimethoprim60 in 1 BOTTLETABLET6023
63629-1765-8Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET3023
63629-1765-9Sulfamethoxazole and Trimethoprim13 in 1 BOTTLETABLET1323

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1765-0EA - Each63629-1765702c5e62-9d16-4d01-9413-8b753607322212016-05-16
63629-1765-1EA - Each63629-17650c4a3fe1-b296-43dc-b946-aa17648eabb812012-07-24
63629-1765-2EA - Each63629-1765f0480513-52b1-47d7-b6ac-e59c15638ce012012-07-24
63629-1765-3EA - Each63629-1765c43a2870-5920-4e06-bd1a-4ff259a523ff12012-07-24
63629-1765-4EA - Each63629-1765858962e5-07e4-4a5f-8f4e-7f27c87dea3712012-07-24
63629-1765-5EA - Each63629-1765af45dd70-1a0e-4195-bd67-4a3f442ea76312012-07-24
63629-1765-6EA - Each63629-17659a2ed065-37ec-41e8-b5f4-3fa13c1179c012012-07-24
63629-1765-7EA - Each63629-1765691523e5-243e-4b49-b681-3c39197fefda12012-07-24
63629-1765-8EA - Each63629-1765062e0a17-deb7-443d-b9f9-6bf649b9348112012-07-24
63629-1765-9EA - Each63629-17659c44bd20-0d62-4081-9e77-b579826f3ff412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BRYANT RANCH PREPACK]3
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BRYANT RANCH PREPACK]3
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BRYANT RANCH PREPACK]3
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BRYANT RANCH PREPACK]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BRYANT RANCH PREPACK]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1765SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BRYANT RANCH PREPACK]23Current NDC, Legacy NDC, 10 package rows20241017_a174991a-53e7-c791-3cee-b706a48e0ec5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNa174991a-53e7-c791-3cee-b706a48e0ec523
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDa174991a-53e7-c791-3cee-b706a48e0ec523
198335SMX 800 MG / TMP 160 MG Oral TabletSYa174991a-53e7-c791-3cee-b706a48e0ec523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1765-06362917650021 TABLET in 1 BOTTLE (63629-1765-0) 21 tablet2010-09-170000-00-00NoNoCurrent
63629-1765-16362917650120 TABLET in 1 BOTTLE (63629-1765-1) 20 tablet2024-10-090000-00-00NoNoCurrent
63629-1765-26362917650214 TABLET in 1 BOTTLE (63629-1765-2) 14 tablet2024-10-090000-00-00NoNoCurrent
63629-1765-36362917650310 TABLET in 1 BOTTLE (63629-1765-3) 10 tablet2024-10-090000-00-00NoNoCurrent
63629-1765-46362917650428 TABLET in 1 BOTTLE (63629-1765-4) 28 tablet2024-10-090000-00-00NoNoCurrent
63629-1765-56362917650540 TABLET in 1 BOTTLE (63629-1765-5) 40 tablet2024-10-090000-00-00NoNoCurrent
63629-1765-6636291765066 TABLET in 1 BOTTLE (63629-1765-6) 6 tablet2024-10-090000-00-00NoNoCurrent
63629-1765-76362917650760 TABLET in 1 BOTTLE (63629-1765-7) 60 tablet2024-10-090000-00-00NoNoCurrent
63629-1765-86362917650830 TABLET in 1 BOTTLE (63629-1765-8) 30 tablet2024-10-090000-00-00NoNoCurrent
63629-1765-96362917650913 TABLET in 1 BOTTLE (63629-1765-9) 13 tablet2024-10-090000-00-00NoNoCurrent