FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
70069-362
11-digit product format
700690362
Labeler code
70069
Product ID
70069-362_012dfac7-9b72-48a5-a364-e62bbe150cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA212231
Marketing category
ANDA
Marketing start
2019-08-29
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
70069-362-01Sulfamethoxazole and Trimethoprim10 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE1010
70069-362-10Sulfamethoxazole and Trimethoprim10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-362-01ML - Milliliter70069-3625de3db62-0758-4dbd-a0f7-aa92d6690d3e12019-11-12
70069-362-10ML - Milliliter70069-3626e7e40d7-3e08-4e9e-99b8-a4ba66cf33e812019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-362SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [SOMERSET THERAPEUTICS, LLC]7Current NDC, Legacy NDC, 2 package rows20230809_ebb570bb-6e5e-489e-875c-9e7b3a6d716a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809083sulfamethoxazole 400 MG / trimethoprim 80 MG in 5 ML InjectionPSNebb570bb-6e5e-489e-875c-9e7b3a6d716a10
313137sulfamethoxazole 80 MG / trimethoprim 16 MG in 1 ML Injectable SolutionPSNebb570bb-6e5e-489e-875c-9e7b3a6d716a10
18090835 ML sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML InjectionSCDebb570bb-6e5e-489e-875c-9e7b3a6d716a10
313137sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML Injectable SolutionSCDebb570bb-6e5e-489e-875c-9e7b3a6d716a10
18090835 ML SMX 80 MG/ML / TMP 16 MG/ML InjectionSYebb570bb-6e5e-489e-875c-9e7b3a6d716a10
313137SMX 80 MG/ML / TMP 16 MG/ML Injectable SolutionSYebb570bb-6e5e-489e-875c-9e7b3a6d716a10
1809083sulfamethoxazole 400 MG / trimethoprim 80 MG per 5 ML InjectionSYebb570bb-6e5e-489e-875c-9e7b3a6d716a10
313137sulfamethoxazole 80 MG / trimethoprim 16 MG per 1 ML Injectable SolutionSYebb570bb-6e5e-489e-875c-9e7b3a6d716a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-362-017006903620110 mL in 1 VIAL10 mlHistorical
70069-362-107006903621010 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) 10 vial2019-08-290000-00-00NoNoCurrent