FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
62135-873
11-digit product format
621350873
Labeler code
62135
Product ID
62135-873_316d17d0-4fb7-a200-e063-6394a90aa5e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA077785
Marketing category
ANDA
Marketing start
2007-01-24
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800; 160 mg/20mL; mg/20mL
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
SULFAMETHOXAZOLE800 mg/20mL
TRIMETHOPRIM160 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAN164J8Y0X, JE42381TNV
Rxcui313134

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
62135-873-24Sulfamethoxazole and Trimethoprim2 in 1 BOXSUSPENSION25
62135-873-24Sulfamethoxazole and Trimethoprim10 in 1 TRAYSUSPENSION105
62135-873-52Sulfamethoxazole and Trimethoprim20 mL in 1 CUPSUSPENSION205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-873-24ML - Milliliter62135-873d1d33c88-88a7-42aa-8056-3b03426afd4b12024-09-09
62135-873-52ML - Milliliter62135-8735193a7a8-0a13-4266-8835-738c899765a712024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-873SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [CHARTWELL RX, LLC]5Current NDC, 3 package rows20250331_b5b7aba5-f93d-46bc-a3c2-712de1c5cff3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNb5b7aba5-f93d-46bc-a3c2-712de1c5cff35
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDb5b7aba5-f93d-46bc-a3c2-712de1c5cff35
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYb5b7aba5-f93d-46bc-a3c2-712de1c5cff35
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYb5b7aba5-f93d-46bc-a3c2-712de1c5cff35
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYb5b7aba5-f93d-46bc-a3c2-712de1c5cff35
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYb5b7aba5-f93d-46bc-a3c2-712de1c5cff35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-873-24621350873242 TRAY in 1 BOX (62135-873-24) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-873-52) 2 tray2024-05-30NoNoCurrent
62135-873-526213508735220 mL in 1 CUP20 mlHistorical