FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
21695-701
11-digit product format
216950701
Labeler code
21695
Product ID
21695-701_3e568a2e-421d-4456-a8bf-d983ecee7ad6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074650
Marketing category
ANDA
Marketing start
1997-12-29
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-701IInactivated by FDA2026-07-31
excluded packagepackage21695-70121695-701-00IInactivated by FDA2026-07-31
excluded packagepackage21695-70121695-701-16IInactivated by FDA2026-07-31

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
A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-29

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 22:54:322026-06A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-29a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-701-002019-09-24C16284748780-1934fe258-4c71-48b1-e053-8cdaa90a720aSulfamethoxazole and Trimethoprim Oral Suspension, USP
21695-701-162019-09-24C16284748780-1934fe258-4c71-48b1-e053-8cdaa90a720aSulfamethoxazole and Trimethoprim Oral Suspension, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-701-00Sulfamethoxazole and Trimethoprim100 mL in 1 BOTTLESUSPENSION1001
21695-701-16Sulfamethoxazole and Trimethoprim473 mL in 1 BOTTLESUSPENSION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-701-16ML - Milliliter21695-701994abfc3-72cf-4a4a-9dfd-dbe7140be17f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
CHERRYINACTIVE INGREDIENTBUC5I9595WSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
SORBITOLINACTIVE INGREDIENT506T60A25RSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-701SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20101210_3e568a2e-421d-4456-a8bf-d983ecee7ad6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN3e568a2e-421d-4456-a8bf-d983ecee7ad61
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD3e568a2e-421d-4456-a8bf-d983ecee7ad61
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY3e568a2e-421d-4456-a8bf-d983ecee7ad61
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY3e568a2e-421d-4456-a8bf-d983ecee7ad61
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY3e568a2e-421d-4456-a8bf-d983ecee7ad61
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY3e568a2e-421d-4456-a8bf-d983ecee7ad61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-701-0021695070100100 mL in 1 BOTTLE100 mlHistorical
21695-701-1621695070116473 mL in 1 BOTTLE473 mlHistorical