FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
0121-4793
11-digit product format
001214793
Labeler code
0121
Product ID
0121-4793_024deb75-5165-4051-960d-e3376f4c8a92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA077612
Marketing category
ANDA
Marketing start
2008-07-02
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200 mg/5mL; mg/5mL
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
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0121-4793DDiscontinued by firm2026-07-31
excluded packagepackage0121-47930121-4793-20DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077612-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALAB2006-11-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077612-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077612-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALAB2006-11-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077612-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMKesin Pharma31f9e720-3869-061f-e063-6294a90a43b42025-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077612
application number: ANDA077612
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPrasco Laboratories6111a3c9-1406-4337-8b55-0f33120af8192024-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077612
application number: ANDA077612

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-4793-202024-08-13C16284748780-1956f9ecf-df05-621f-e053-dbdaa90a74adSULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION USP
0121-4793-202019-10-21C16284748780-1956f9ecf-df05-621f-e053-dbdaa90a74adSULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4793-20ML - Milliliter0121-47938b2681a7-24ae-4b44-a7ee-ca64d0d15d9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SulfamethoxazoleACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
TrimethoprimACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
SulfamethoxazoleACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
TrimethoprimACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1