FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
0703-9503
11-digit product format
007039503
Labeler code
0703
Product ID
0703-9503_75bddfb3-c199-47a4-b54a-a74cef7dec9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA073303
Marketing category
ANDA
Marketing start
1991-11-01
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
80; 16 mg/mL; mg/mL
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
SULFAMETHOXAZOLE80 mg/mL
TRIMETHOPRIM16 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAN164J8Y0X, JE42381TNV
Rxcui313137, 1809083

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0703-9503-01Sulfamethoxazole and Trimethoprim5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE518
0703-9503-03Sulfamethoxazole and Trimethoprim10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE1018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-9503-01ML - Milliliter0703-9503f616736c-aa21-4814-97ce-34c43124b90612021-05-05
0703-9503-03ML - Milliliter0703-9503afbb5a59-dbfa-4b31-a67e-2eb5606f3d1812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
ALCOHOLINACTIVE INGREDIENT3K9958V90MSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
DIETHANOLAMINEINACTIVE INGREDIENTAZE05TDV2VSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0703-9503SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]17Current NDC, Legacy NDC, 2 package rows20250510_b89b5502-ce87-45a6-a43c-9891da3cfca4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809083sulfamethoxazole 400 MG / trimethoprim 80 MG in 5 ML InjectionPSNb89b5502-ce87-45a6-a43c-9891da3cfca418
313137sulfamethoxazole 80 MG / trimethoprim 16 MG in 1 ML Injectable SolutionPSNb89b5502-ce87-45a6-a43c-9891da3cfca418
18090835 ML sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML InjectionSCDb89b5502-ce87-45a6-a43c-9891da3cfca418
313137sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML Injectable SolutionSCDb89b5502-ce87-45a6-a43c-9891da3cfca418
18090835 ML SMX 80 MG/ML / TMP 16 MG/ML InjectionSYb89b5502-ce87-45a6-a43c-9891da3cfca418
313137SMX 80 MG/ML / TMP 16 MG/ML Injectable SolutionSYb89b5502-ce87-45a6-a43c-9891da3cfca418
1809083sulfamethoxazole 400 MG / trimethoprim 80 MG per 5 ML InjectionSYb89b5502-ce87-45a6-a43c-9891da3cfca418
313137sulfamethoxazole 80 MG / trimethoprim 16 MG per 1 ML Injectable SolutionSYb89b5502-ce87-45a6-a43c-9891da3cfca418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0703-9503-01007039503015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0703-9503-030070395030310 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) 1991-11-010000-00-00NoNoCurrent