FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
62135-897
11-digit product format
621350897
Labeler code
62135
Product ID
62135-897_10445eb8-e525-d945-e063-6294a90ae0f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA078060
Marketing category
ANDA
Marketing start
2007-01-25
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
400; 80 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE400 mg/1
TRIMETHOPRIM80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui198334, 198335

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
62135-897-18Sulfamethoxazole and Trimethoprim180 in 1 BOTTLETABLET1801
62135-897-90Sulfamethoxazole and Trimethoprim90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-897-18EA - Each62135-8971afbe5cc-3126-453f-992d-0c3701f922ed12024-03-12
62135-897-90EA - Each62135-897405e0347-2a4c-4a6f-a6e5-e13fc4f14ea412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-897SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CHARTWELL RX, LLC]1Current NDC, 2 package rows20240202_e4a7572f-b372-40eb-963f-919ac100b7a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSNe4a7572f-b372-40eb-963f-919ac100b7a81
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNe4a7572f-b372-40eb-963f-919ac100b7a81
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCDe4a7572f-b372-40eb-963f-919ac100b7a81
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDe4a7572f-b372-40eb-963f-919ac100b7a81
198334SMX 400 MG / TMP 80 MG Oral TabletSYe4a7572f-b372-40eb-963f-919ac100b7a81
198335SMX 800 MG / TMP 160 MG Oral TabletSYe4a7572f-b372-40eb-963f-919ac100b7a81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-897-1862135089718180 TABLET in 1 BOTTLE (62135-897-18) 180 tablet2024-01-11NoNoHistorical
62135-897-906213508979090 TABLET in 1 BOTTLE (62135-897-90) 90 tablet2024-01-11NoNoHistorical