Sulfamethoxazole and Trimethoprim

Product NDC
17856-5181
11-digit product format
178565181
Labeler code
17856
Product ID
17856-5181_4b1ecd4a-5752-4ef8-8946-2abcb60e86ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA077785
Marketing category
ANDA
Marketing start
2007-01-24
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200 mg/5mL; mg/5mL
Pharmacologic classes
Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-5181-1Sulfamethoxazole and Trimethoprim5 mL in 1 CUP, UNIT-DOSESUSPENSION51
17856-5181-1Sulfamethoxazole and Trimethoprim72 in 1 BOX, UNIT-DOSESUSPENSION721
17856-5181-2Sulfamethoxazole and Trimethoprim10 mL in 1 CUP, UNIT-DOSESUSPENSION101
17856-5181-2Sulfamethoxazole and Trimethoprim72 in 1 BOX, UNIT-DOSESUSPENSION721
17856-5181-3Sulfamethoxazole and Trimethoprim20 mL in 1 CUP, UNIT-DOSESUSPENSION201
17856-5181-3Sulfamethoxazole and Trimethoprim50 in 1 BOX, UNIT-DOSESUSPENSION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-5181SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 6 package rows20201028_e2a018ad-31aa-47d2-b96b-e7a1deee0976.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNe2a018ad-31aa-47d2-b96b-e7a1deee09761
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDe2a018ad-31aa-47d2-b96b-e7a1deee09761
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYe2a018ad-31aa-47d2-b96b-e7a1deee09761
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYe2a018ad-31aa-47d2-b96b-e7a1deee09761
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYe2a018ad-31aa-47d2-b96b-e7a1deee09761
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYe2a018ad-31aa-47d2-b96b-e7a1deee09761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-5181-11785651810172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5181-1) > 5 mL in 1 CUP, UNIT-DOSE2020-10-270000-00-00NoNoCurrent
17856-5181-21785651810272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5181-2) > 10 mL in 1 CUP, UNIT-DOSE2020-10-270000-00-00NoNoCurrent
17856-5181-31785651810350 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5181-3) > 20 mL in 1 CUP, UNIT-DOSE2020-10-270000-00-00NoNoCurrent