FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50090-2198
11-digit product format
500902198
Labeler code
50090
Product ID
50090-2198_94eb5763-343f-4db3-8007-d7ce5c06ee41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
Rxcui198335

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
50090-2198-02023-02-07C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-12023-02-07C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-22023-02-07C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-32023-02-07C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-52023-02-07C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-72023-02-07C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-02023-01-30C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-12023-01-30C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-22023-01-30C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-32023-01-30C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-52023-01-30C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2198-72023-01-30C16284748780-1f386c64a-43ff-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2198-0Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET1016
50090-2198-1Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET1416
50090-2198-2Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET2016
50090-2198-3Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET2816
50090-2198-5Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET10016
50090-2198-7Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET616

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2198-0EA - Each50090-21984ee1223a-9654-4d9f-93aa-a61aa6efa81312019-02-13
50090-2198-1EA - Each50090-2198c032f6cc-439e-464b-9207-0177b66e8f0812018-11-06
50090-2198-2EA - Each50090-2198ed602797-7a82-4982-bff5-5a6fb9390e0212018-11-06
50090-2198-3EA - Each50090-21983667da59-cd97-4a80-ab68-460f471e5cbc12018-11-06
50090-2198-5EA - Each50090-21981be1b343-4f25-4b4a-ad6e-4621f4e73f7812018-11-06
50090-2198-7EA - Each50090-2198414d5a45-0daa-4a1c-aa88-6c71d001722812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2198SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 6 package rows20250403_14767ff8-7803-4922-ac03-ff80c061e5ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN14767ff8-7803-4922-ac03-ff80c061e5ba16
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD14767ff8-7803-4922-ac03-ff80c061e5ba16
198335SMX 800 MG / TMP 160 MG Oral TabletSY14767ff8-7803-4922-ac03-ff80c061e5ba16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2198-05009021980010 TABLET in 1 BOTTLE (50090-2198-0) 10 tablet2015-10-280000-00-00NoNoCurrent
50090-2198-15009021980114 TABLET in 1 BOTTLE (50090-2198-1) 14 tablet2015-10-280000-00-00NoNoCurrent
50090-2198-25009021980220 TABLET in 1 BOTTLE (50090-2198-2) 20 tablet2015-10-280000-00-00NoNoCurrent
50090-2198-35009021980328 TABLET in 1 BOTTLE (50090-2198-3) 28 tablet2015-10-280000-00-00NoNoCurrent
50090-2198-550090219805100 TABLET in 1 BOTTLE (50090-2198-5) 100 tablet2015-10-280000-00-00NoNoCurrent
50090-2198-7500902198076 TABLET in 1 BOTTLE (50090-2198-7) 6 tablet2015-10-280000-00-00NoNoCurrent