FDA.reportPublic FDA data

SULFATRIM

Product NDC
68788-7345
11-digit product format
687887345
Labeler code
68788
Product ID
68788-7345_5b51ac80-49b2-4027-a374-fc78a0e28bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
NDA018615
Marketing category
NDA
Marketing start
2020-06-01
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
SULFATRIM
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
Rxcui208406, 313134

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
68788-7345-4SULFATRIM473 mL in 1 BOTTLESUSPENSION4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7345-4ML - Milliliter68788-7345baf6e339-7f58-4c27-98d2-c76ab73c0e1812020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7345SULFATRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20250119_cd4932ce-0856-4e99-8baf-70afce1d7ffd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNcd4932ce-0856-4e99-8baf-70afce1d7ffd6
208406SULFATRIM 200 MG / 40 MG in 5 mL Oral SuspensionPSNcd4932ce-0856-4e99-8baf-70afce1d7ffd6
208406sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]SBDcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
208406SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]SYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
208406Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral SuspensionSYcd4932ce-0856-4e99-8baf-70afce1d7ffd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7345-468788734504473 mL in 1 BOTTLE (68788-7345-4) 473 ml2020-06-010000-00-00NoNoCurrent