FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
66993-727
11-digit product format
669930727
Labeler code
66993
Product ID
66993-727_cc7ce9be-e89e-4682-8d14-0902ba36b47a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfamethoxazole and trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Prasco Laboratories
Application
ANDA077612
Marketing category
ANDA
Marketing start
2022-07-05
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200; 40 mg/5mL; mg/5mL
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

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TRIMETHOPRIM200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALAB2006-11-13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AND TRIMETHOPRIM200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALAB2006-11-13a50c72e98297…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
ndc (product): 66993-727

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE200 mg/5mL
TRIMETHOPRIM40 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JE42381TNVInternal UNII lookup
AN164J8Y0XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313134Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6111a3c9-1406-4337-8b55-0f33120af819Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-727-57Sulfamethoxazole and Trimethoprim473 mL in 1 BOTTLE, PLASTICSUSPENSION4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-727-57ML - Milliliter66993-727266a1ddd-653f-418d-8c37-23a01b1164e412022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-727SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PRASCO LABORATORIES]9Current NDC, Legacy NDC, 1 package rows20241213_6111a3c9-1406-4337-8b55-0f33120af819.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN6111a3c9-1406-4337-8b55-0f33120af8199
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD6111a3c9-1406-4337-8b55-0f33120af8199
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY6111a3c9-1406-4337-8b55-0f33120af8199
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY6111a3c9-1406-4337-8b55-0f33120af8199
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY6111a3c9-1406-4337-8b55-0f33120af8199
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY6111a3c9-1406-4337-8b55-0f33120af8199
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN115eb7fc-4ad0-b7f5-e063-6294a90a21c52
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN31f9e720-3869-061f-e063-6294a90a43b42
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD31f9e720-3869-061f-e063-6294a90a43b42
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD115eb7fc-4ad0-b7f5-e063-6294a90a21c52
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY31f9e720-3869-061f-e063-6294a90a43b42
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY115eb7fc-4ad0-b7f5-e063-6294a90a21c52
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY31f9e720-3869-061f-e063-6294a90a43b42
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY115eb7fc-4ad0-b7f5-e063-6294a90a21c52
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY115eb7fc-4ad0-b7f5-e063-6294a90a21c52
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY31f9e720-3869-061f-e063-6294a90a43b42
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY31f9e720-3869-061f-e063-6294a90a43b42
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY115eb7fc-4ad0-b7f5-e063-6294a90a21c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-727-5766993072757473 mL in 1 BOTTLE, PLASTIC (66993-727-57) 473 ml2022-07-050000-00-00NoNoCurrent