Sulfamethoxazole and Trimethoprim

Product NDC
55695-008
11-digit product format
556950008
Labeler code
55695
Product ID
55695-008_2dc8a875-7d63-2544-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Department of State Health Services, Pharmacy Branch
Application
ANDA078060
Marketing category
ANDA
Marketing start
2007-01-25
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55695-008-002020-01-31C16284748780-19d75b9d0-b728-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP, 800 mg/160 mg (DOUBLE STRENGTH) AND 400 mg/80 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55695-008-00Sulfamethoxazole and Trimethoprim100 in 1 BOTTLE, PLASTICTABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55695-008SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH]2Legacy NDC, 1 package rows20160311_2b5f951e-4bb2-2c1f-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN2b5f951e-4bb2-2c1f-e054-00144ff8d46c2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD2b5f951e-4bb2-2c1f-e054-00144ff8d46c2
198335SMX 800 MG / TMP 160 MG Oral TabletSY2b5f951e-4bb2-2c1f-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55695-008-0055695000800100 in 1 BOTTLE, PLASTICHistorical