FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
52959-144
11-digit product format
529590144
Labeler code
52959
Product ID
52959-144_7b3d09bc-e5df-4fcf-941b-c19686900623
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-09-13
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 mg/1; mg/1
Pharmacologic classes
Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
52959-144-002020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
52959-144-062020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
52959-144-102020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
52959-144-142020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
52959-144-152020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
52959-144-202020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
52959-144-212020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
52959-144-282020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
52959-144-302020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
52959-144-402020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
52959-144-602020-01-31C16284748780-19d75b9d0-cde1-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-144-00Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET1002
52959-144-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET62
52959-144-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET102
52959-144-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET142
52959-144-15Sulfamethoxazole and Trimethoprim15 in 1 BOTTLETABLET152
52959-144-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET202
52959-144-21Sulfamethoxazole and Trimethoprim21 in 1 BOTTLETABLET212
52959-144-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET282
52959-144-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET302
52959-144-40Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET402
52959-144-60Sulfamethoxazole and Trimethoprim60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-144-00EA - Each52959-144d9bbb2e2-96ba-4d24-af7c-d2c64f743e7a12012-07-24
52959-144-06EA - Each52959-1440ddba57f-4f49-4c57-8cd5-378e99989e2412012-07-24
52959-144-10EA - Each52959-1446fc85fb5-7b42-4064-b6cc-f5da4d5f51e012012-07-24
52959-144-14EA - Each52959-144310edc3c-15e8-43b7-b13c-f2eaff60672d12012-07-24
52959-144-15EA - Each52959-144350564f6-e114-42f4-be17-517ab0b637b712012-07-24
52959-144-20EA - Each52959-1449a609964-9270-4c87-b8fa-049979bf32c712012-07-24
52959-144-21EA - Each52959-144678355a2-b805-4e7f-aee9-3b267219c4a312012-07-24
52959-144-28EA - Each52959-144eaec8e4f-f0e4-4ef0-a9ce-7d041d773eb812012-07-24
52959-144-30EA - Each52959-1448ec264b9-3166-4a3f-8863-7615150853e312012-07-24
52959-144-40EA - Each52959-144ff44c748-2d37-4efc-9121-e3adb09edcda12012-07-24
52959-144-60EA - Each52959-1443f8e4cf6-ef35-475e-a656-19b9d34d513f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [H.J. HARKINS COMPANY, INC.]2
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [H.J. HARKINS COMPANY, INC.]2
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [H.J. HARKINS COMPANY, INC.]2
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-144SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 11 package rows20111222_27ca999f-2678-4c7d-8f7d-895d0fe77a9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN27ca999f-2678-4c7d-8f7d-895d0fe77a9f2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD27ca999f-2678-4c7d-8f7d-895d0fe77a9f2
198335SMX 800 MG / TMP 160 MG Oral TabletSY27ca999f-2678-4c7d-8f7d-895d0fe77a9f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-144-0052959014400100 in 1 BOTTLEHistorical
52959-144-06529590144066 in 1 BOTTLEHistorical
52959-144-105295901441010 in 1 BOTTLEHistorical
52959-144-145295901441414 in 1 BOTTLEHistorical
52959-144-155295901441515 in 1 BOTTLEHistorical
52959-144-205295901442020 in 1 BOTTLEHistorical
52959-144-215295901442121 in 1 BOTTLEHistorical
52959-144-285295901442828 in 1 BOTTLEHistorical
52959-144-305295901443030 in 1 BOTTLEHistorical
52959-144-405295901444040 in 1 BOTTLEHistorical
52959-144-605295901446060 in 1 BOTTLEHistorical