Sulfamethoxazole and Trimethoprim

Product NDC
67296-1612
11-digit product format
672961612
Labeler code
67296
Product ID
67296-1612_d61c3e86-1855-9f4c-e053-2a95a90a94fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 mg/1; mg/1
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
2023-12-31
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
67296-1612-1Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET1010
67296-1612-2Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET2010
67296-1612-4Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET1410
67296-1612-6Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET610

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1612SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REDPHARM DRUG, INC.]10Legacy NDC, 4 package rows20240725_7b220787-cf13-6f50-e053-2a91aa0aab6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN7b220787-cf13-6f50-e053-2a91aa0aab6e10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD7b220787-cf13-6f50-e053-2a91aa0aab6e10
198335SMX 800 MG / TMP 160 MG Oral TabletSY7b220787-cf13-6f50-e053-2a91aa0aab6e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1612-16729616120110 TABLET in 1 BOTTLE (67296-1612-1) 10 tablet2018-01-010000-00-00NoNoCurrent
67296-1612-26729616120220 TABLET in 1 BOTTLE (67296-1612-2) 20 tablet2018-01-010000-00-00NoNoCurrent
67296-1612-46729616120414 TABLET in 1 BOTTLE (67296-1612-4) 14 tablet2018-01-010000-00-00NoNoCurrent
67296-1612-6672961612066 TABLET in 1 BOTTLE (67296-1612-6) 6 tablet2018-01-010000-00-00NoNoCurrent