Sulfamethoxazole and Trimethoprim

Product NDC
67457-778
11-digit product format
674570778
Labeler code
67457
Product ID
67457-778_aa80137a-281f-41cd-b8df-0f08df701854
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfamethoxazole and trimethoprim
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA206607
Marketing category
ANDA
Marketing start
2017-12-31
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
80 mg/mL; mg/mL
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
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-778-00ML - Milliliter67457-778152e7753-c83d-4988-8098-2546de21be6f12017-11-06
67457-778-05ML - Milliliter67457-77852d86b25-ecb9-490a-a31b-4cd7cca94a8112017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-778SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION [MYLAN INSTITUTIONAL LLC]7Legacy NDC20250104_793c75eb-dd65-4b6d-ac46-6e57ce1334f7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-778-056745707780510 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) > 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00) 2017-12-310000-00-00NoNoCurrent