FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
57237-233
11-digit product format
572370233
Labeler code
57237
Product ID
57237-233_a7ba2917-7474-437f-8c18-a2f06c2c8bd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800; 160 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
SULFAMETHOXAZOLE800 mg/1
TRIMETHOPRIM160 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-233-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET10010
57237-233-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-233SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 2 package rows20250412_e1a3748d-ca73-4e56-95ad-d25189cc346e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNc45ac3a4-d397-486e-abd1-34991654306825
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDc45ac3a4-d397-486e-abd1-34991654306825
198335SMX 800 MG / TMP 160 MG Oral TabletSYc45ac3a4-d397-486e-abd1-34991654306825
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN079c828c-148f-45b9-966e-d8906043b2a212
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD079c828c-148f-45b9-966e-d8906043b2a212
198335SMX 800 MG / TMP 160 MG Oral TabletSY079c828c-148f-45b9-966e-d8906043b2a212
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN27bebe39-c069-4a9d-99d1-c7cf44ac2f4111
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD27bebe39-c069-4a9d-99d1-c7cf44ac2f4111
198335SMX 800 MG / TMP 160 MG Oral TabletSY27bebe39-c069-4a9d-99d1-c7cf44ac2f4111
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSNe1a3748d-ca73-4e56-95ad-d25189cc346e10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN7b220787-cf13-6f50-e053-2a91aa0aab6e10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNe1a3748d-ca73-4e56-95ad-d25189cc346e10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNec2e335c-3357-40d8-9615-a09fc40ce5f410
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCDe1a3748d-ca73-4e56-95ad-d25189cc346e10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDec2e335c-3357-40d8-9615-a09fc40ce5f410
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDe1a3748d-ca73-4e56-95ad-d25189cc346e10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD7b220787-cf13-6f50-e053-2a91aa0aab6e10
198334SMX 400 MG / TMP 80 MG Oral TabletSYe1a3748d-ca73-4e56-95ad-d25189cc346e10
198335SMX 800 MG / TMP 160 MG Oral TabletSYec2e335c-3357-40d8-9615-a09fc40ce5f410
198335SMX 800 MG / TMP 160 MG Oral TabletSYe1a3748d-ca73-4e56-95ad-d25189cc346e10
198335SMX 800 MG / TMP 160 MG Oral TabletSY7b220787-cf13-6f50-e053-2a91aa0aab6e10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNafe8cb1c-7cfd-3378-e053-2a95a90a4db68
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDafe8cb1c-7cfd-3378-e053-2a95a90a4db68
198335SMX 800 MG / TMP 160 MG Oral TabletSYafe8cb1c-7cfd-3378-e053-2a95a90a4db68
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN90026ce8-3305-6272-e053-2995a90a57e07
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD90026ce8-3305-6272-e053-2995a90a57e07
198335SMX 800 MG / TMP 160 MG Oral TabletSY90026ce8-3305-6272-e053-2995a90a57e07
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNd60c218c-6529-4944-af0b-a9dc720f32e96
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN7f82e5e0-b627-a3f3-e053-2991aa0abaa56
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDd60c218c-6529-4944-af0b-a9dc720f32e96
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD7f82e5e0-b627-a3f3-e053-2991aa0abaa56
198335SMX 800 MG / TMP 160 MG Oral TabletSYd60c218c-6529-4944-af0b-a9dc720f32e96
198335SMX 800 MG / TMP 160 MG Oral TabletSY7f82e5e0-b627-a3f3-e053-2991aa0abaa56
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNbefcc5b0-04bb-4211-b3dd-88f400c7fa785
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN8c3e4738-0e0a-a854-e053-2995a90a7d715
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN8c74ea5c-d05e-4fc1-b980-aacaab56d4725
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDbefcc5b0-04bb-4211-b3dd-88f400c7fa785
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD8c3e4738-0e0a-a854-e053-2995a90a7d715
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD8c74ea5c-d05e-4fc1-b980-aacaab56d4725
198335SMX 800 MG / TMP 160 MG Oral TabletSYbefcc5b0-04bb-4211-b3dd-88f400c7fa785
198335SMX 800 MG / TMP 160 MG Oral TabletSY8c3e4738-0e0a-a854-e053-2995a90a7d715
198335SMX 800 MG / TMP 160 MG Oral TabletSY8c74ea5c-d05e-4fc1-b980-aacaab56d4725
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNe3a49508-0ebe-1334-e053-2a95a90ae1734
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDe3a49508-0ebe-1334-e053-2a95a90ae1734
198335SMX 800 MG / TMP 160 MG Oral TabletSYe3a49508-0ebe-1334-e053-2a95a90ae1734
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN20054147-811c-471a-8ec4-1b2903fe906e3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNa12fb7b0-9ff5-48f1-8fd9-4fbdfdbe09bc3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNa12bf393-d8ef-48df-e053-2a95a90a1af13
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN75b9d194-b960-4943-bedc-96e3d65c4da93
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNf450526c-ec39-45e1-acf1-b13833ba25703
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD20054147-811c-471a-8ec4-1b2903fe906e3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD75b9d194-b960-4943-bedc-96e3d65c4da93
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDf450526c-ec39-45e1-acf1-b13833ba25703
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDa12bf393-d8ef-48df-e053-2a95a90a1af13
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDa12fb7b0-9ff5-48f1-8fd9-4fbdfdbe09bc3
198335SMX 800 MG / TMP 160 MG Oral TabletSYf450526c-ec39-45e1-acf1-b13833ba25703
198335SMX 800 MG / TMP 160 MG Oral TabletSYa12bf393-d8ef-48df-e053-2a95a90a1af13
198335SMX 800 MG / TMP 160 MG Oral TabletSY20054147-811c-471a-8ec4-1b2903fe906e3
198335SMX 800 MG / TMP 160 MG Oral TabletSYa12fb7b0-9ff5-48f1-8fd9-4fbdfdbe09bc3
198335SMX 800 MG / TMP 160 MG Oral TabletSY75b9d194-b960-4943-bedc-96e3d65c4da93
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNe6c0f80a-ba22-4690-aaf8-48a4602b68312
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNf564a029-4b20-301a-e053-2995a90adcc02
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN471c5995-a4df-fbe3-e063-6394a90aa50e2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN52304e5e-d097-48f2-8b64-210908e4eb542
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN7d7ca48b-8655-4cfb-8db0-28eddf1feb9b2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDf564a029-4b20-301a-e053-2995a90adcc02
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD471c5995-a4df-fbe3-e063-6394a90aa50e2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDe6c0f80a-ba22-4690-aaf8-48a4602b68312
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD52304e5e-d097-48f2-8b64-210908e4eb542
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD7d7ca48b-8655-4cfb-8db0-28eddf1feb9b2
198335SMX 800 MG / TMP 160 MG Oral TabletSYe6c0f80a-ba22-4690-aaf8-48a4602b68312
198335SMX 800 MG / TMP 160 MG Oral TabletSYf564a029-4b20-301a-e053-2995a90adcc02
198335SMX 800 MG / TMP 160 MG Oral TabletSY52304e5e-d097-48f2-8b64-210908e4eb542
198335SMX 800 MG / TMP 160 MG Oral TabletSY471c5995-a4df-fbe3-e063-6394a90aa50e2
198335SMX 800 MG / TMP 160 MG Oral TabletSY7d7ca48b-8655-4cfb-8db0-28eddf1feb9b2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN87240462-3840-5045-e053-2991aa0a43411
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN7cc4029e-5f4b-880a-e053-2991aa0a32641
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN518cc045-a12b-f08f-e063-6394a90acb0c1
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN8cb4ed51-aa27-f6e6-e053-2a95a90a7df51
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN8de58d77-c631-2b9d-e053-2995a90a54ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-233-0157237023301100 TABLET in 1 BOTTLE (57237-233-01) 100 tablet2010-02-160000-00-00NoNoCurrent
57237-233-0557237023305500 TABLET in 1 BOTTLE (57237-233-05) 500 tablet2010-02-160000-00-00NoNoCurrent