FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
68999-873
11-digit product format
689990873
Labeler code
68999
Product ID
68999-873_4b94985f-5d68-840b-e063-6294a90ac04a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chartwell Governmental & Specialty 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE800 mg/20mL
TRIMETHOPRIM160 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui313134

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-873-24Sulfamethoxazole and Trimethoprim2 in 1 BOXSUSPENSION21
68999-873-24Sulfamethoxazole and Trimethoprim10 in 1 TRAYSUSPENSION101
68999-873-52Sulfamethoxazole and Trimethoprim20 mL in 1 CUPSUSPENSION201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN2a5173ba-047d-4a80-81fb-7154265ae3d11
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD2a5173ba-047d-4a80-81fb-7154265ae3d11
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY2a5173ba-047d-4a80-81fb-7154265ae3d11
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY2a5173ba-047d-4a80-81fb-7154265ae3d11
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY2a5173ba-047d-4a80-81fb-7154265ae3d11
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY2a5173ba-047d-4a80-81fb-7154265ae3d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-873-24689990873242 TRAY in 1 BOX (68999-873-24) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-873-52) 2 tray2026-02-18NoNoHistorical
68999-873-526899908735220 mL in 1 CUP20 mlHistorical