Sulfamethoxazole and Trimethoprim DS

Product NDC
12634-177
11-digit product format
126340177
Labeler code
12634
Product ID
12634-177_db550e63-43dc-4126-b857-010383501dd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim DS
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA076899
Marketing category
ANDA
Marketing start
1994-06-21
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 mg/1; mg/1
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
E
Listing certified through
2018-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-177-00Sulfamethoxazole and Trimethoprim DS10 in 1 BOTTLETABLET101
12634-177-59Sulfamethoxazole and Trimethoprim DS30 in 1 BLISTER PACKTABLET301
12634-177-71Sulfamethoxazole and Trimethoprim DS30 in 1 BOTTLETABLET301
12634-177-80Sulfamethoxazole and Trimethoprim DS20 in 1 BOTTLETABLET201
12634-177-84Sulfamethoxazole and Trimethoprim DS14 in 1 BOTTLETABLET141
12634-177-91Sulfamethoxazole and Trimethoprim DS1 in 1 BLISTER PACKTABLET11
12634-177-92Sulfamethoxazole and Trimethoprim DS2 in 1 BOTTLETABLET21
12634-177-96Sulfamethoxazole and Trimethoprim DS6 in 1 BOTTLETABLET61

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-177SULFAMETHOXAZOLE AND TRIMETHOPRIM DS TABLET [APOTHECA INC.]1Legacy NDC, 8 package rows20100429_38f42bad-6b2a-423d-af66-0e526ba03da1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN38f42bad-6b2a-423d-af66-0e526ba03da11
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD38f42bad-6b2a-423d-af66-0e526ba03da11
198335SMX 800 MG / TMP 160 MG Oral TabletSY38f42bad-6b2a-423d-af66-0e526ba03da11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-177-001263401770010 in 1 BOTTLEHistorical
12634-177-591263401775930 in 1 BLISTER PACKHistorical
12634-177-711263401777130 in 1 BOTTLEHistorical
12634-177-801263401778020 in 1 BOTTLEHistorical
12634-177-841263401778414 in 1 BOTTLEHistorical
12634-177-91126340177911 in 1 BLISTER PACKHistorical
12634-177-92126340177922 in 1 BOTTLEHistorical
12634-177-96126340177966 in 1 BOTTLEHistorical