FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
81033-012
11-digit product format
810330012
Labeler code
81033
Product ID
81033-012_35063fad-e644-2b68-e063-6394a90aedc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kesin Pharma
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

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 Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui313134

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
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
81033-012-20Sulfamethoxazole and Trimethoprim20 mL in 1 CUP, UNIT-DOSESUSPENSION202
81033-012-40Sulfamethoxazole and Trimethoprim40 in 1 CARTONSUSPENSION402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-012-20ML - Milliliter81033-0129c8d9407-21d1-4ca2-9186-8d6491bc15a812025-06-13
81033-012-40ML - Milliliter81033-0121f616f91-91c5-4c39-b1c8-d52190240d4612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-012SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [KESIN PHARMA]2Current NDC, 2 package rows20250515_31f9e720-3869-061f-e063-6294a90a43b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY31f9e720-3869-061f-e063-6294a90a43b42
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY31f9e720-3869-061f-e063-6294a90a43b42
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-012-208103300122020 mL in 1 CUP, UNIT-DOSE20 mlHistorical
81033-012-408103300124040 CUP, UNIT-DOSE in 1 CARTON (81033-012-40) / 20 mL in 1 CUP, UNIT-DOSE (81033-012-20) 2025-04-04NoNoHistorical