FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50268-728
11-digit product format
502680728
Labeler code
50268
Product ID
50268-728_4dc8749f-1066-8d9a-e063-6294a90ac636
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA090624
Marketing category
ANDA
Marketing start
2014-09-23
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
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
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
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
50268-728-152022-02-03C16284748780-1d6a99b39-a140-a426-e053-dadaa90af4c2Sulfamethoxazole and Trimethoprim Tablets, USP
50268-728-152022-02-03C16284748780-1d6a99b39-a140-a426-e053-dadaa90af4c2Sulfamethoxazole and Trimethoprim Tablets, USP
50268-728-152022-02-03C16284748780-1d6a99b39-a140-a426-e053-dadaa90af4c2Sulfamethoxazole and Trimethoprim Tablets, USP
50268-728-152022-01-28C16284748780-1d6a99b39-a140-a426-e053-dadaa90af4c2Sulfamethoxazole and Trimethoprim Tablets, USP
50268-728-152022-01-28C16284748780-1d6a99b39-a140-a426-e053-dadaa90af4c2Sulfamethoxazole and Trimethoprim Tablets, USP
50268-728-152022-01-28C16284748780-1d6a99b39-a140-a426-e053-dadaa90af4c2Sulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-728-11Sulfamethoxazole and Trimethoprim1 in 1 BLISTER PACKTABLET110
50268-728-15Sulfamethoxazole and Trimethoprim50 in 1 BOX, UNIT-DOSETABLET5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-728-11EA - Each50268-728e72436bc-6c4a-4a54-aac6-18ff6b0c3d5412014-12-01
50268-728-15EA - Each50268-728aeb76d4b-d456-49b0-bb7f-992d06b9d1ee12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-728SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]8Current NDC, Legacy NDC, 2 package rows20240110_29df8839-3dfa-0b2b-c5a3-906db6997b3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198334SMX 400 MG / TMP 80 MG Oral TabletSY29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198335SMX 800 MG / TMP 160 MG Oral TabletSY29df8839-3dfa-0b2b-c5a3-906db6997b3b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-728-11502680728111 in 1 BLISTER PACKHistorical
50268-728-155026807281550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11) 50 blister pack2014-09-230000-00-00NoNoCurrent