FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
17856-0496
11-digit product format
178560496
Labeler code
17856
Product ID
17856-0496_361f7b6e-a67d-c21a-e063-6394a90ad8ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA091348
Marketing category
ANDA
Marketing start
2017-10-04
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200; 40 mg/5mL; mg/5mL
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
SULFAMETHOXAZOLE200 mg/5mL
TRIMETHOPRIM40 mg/5mL

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
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0496-42024-04-12C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-52024-04-12C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-62024-04-12C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-42024-01-30C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-52024-01-30C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-62024-01-30C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-12021-08-27C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-22021-08-27C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-32021-08-27C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-12021-01-29C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-22021-01-29C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
17856-0496-32021-01-29C16284748780-1ba0f9c33-1425-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0496-1Sulfamethoxazole and Trimethoprim5 mL in 1 CUP, UNIT-DOSESUSPENSION57
17856-0496-2Sulfamethoxazole and Trimethoprim10 mL in 1 CUP, UNIT-DOSESUSPENSION107
17856-0496-3Sulfamethoxazole and Trimethoprim20 mL in 1 CUP, UNIT-DOSESUSPENSION207
17856-0496-4Sulfamethoxazole and Trimethoprim72 in 1 BOXSUSPENSION727
17856-0496-5Sulfamethoxazole and Trimethoprim50 in 1 BOXSUSPENSION507
17856-0496-6Sulfamethoxazole and Trimethoprim72 in 1 BOXSUSPENSION727

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0496-1ML - Milliliter17856-049644c65ddd-5a3c-4f08-bf84-1e7ec142adcc12019-10-07
17856-0496-2ML - Milliliter17856-04969564ea84-9718-4a60-857b-cedf2446bdda12024-11-05
17856-0496-3ML - Milliliter17856-0496367ec1d0-72a6-4895-a508-b9994ff4711212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0496SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORP.]7Current NDC, Legacy NDC, 6 package rows20250529_acc3df02-1e99-46e6-8a31-9b26261c6daa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYacc3df02-1e99-46e6-8a31-9b26261c6daa7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0496-1178560496015 mL in 1 CUP, UNIT-DOSE (17856-0496-1) 5 ml2021-08-270000-00-00NoNoCurrent
17856-0496-21785604960210 mL in 1 CUP, UNIT-DOSE (17856-0496-2) 10 ml2021-08-270000-00-00NoNoCurrent
17856-0496-31785604960320 mL in 1 CUP, UNIT-DOSE (17856-0496-3) 20 ml2021-08-270000-00-00NoNoCurrent
17856-0496-41785604960472 CUP, UNIT-DOSE in 1 BOX (17856-0496-4) / 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1) 2024-04-120000-00-00NoNoCurrent
17856-0496-51785604960550 CUP, UNIT-DOSE in 1 BOX (17856-0496-5) / 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3) 2024-04-120000-00-00NoNoCurrent
17856-0496-61785604960672 CUP, UNIT-DOSE in 1 BOX (17856-0496-6) / 10 mL in 1 CUP, UNIT-DOSE (17856-0496-2) 2024-04-120000-00-00NoNoCurrent