FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
53002-2100
11-digit product format
530022100
Labeler code
53002
Product ID
53002-2100_d91e3632-88a5-412b-be88-e044cd90b0ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 mg/1; mg/1
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-2100-12025-01-30C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-22025-01-30C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-32025-01-30C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-42025-01-30C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-52025-01-30C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-12023-06-07C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-22023-06-07C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-32023-06-07C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-42023-06-07C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-52023-06-07C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-12023-01-30C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-22023-01-30C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-32023-01-30C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-42023-01-30C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-52023-01-30C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-12020-12-16C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-22020-12-16C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-32020-12-16C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-42020-12-16C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-52020-12-16C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-12020-01-31C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-22020-01-31C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-32020-01-31C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-42020-01-31C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP
53002-2100-52020-01-31C16284748780-19d75b9d0-17ec-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2100-1Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET65
53002-2100-2Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET105
53002-2100-3Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET145
53002-2100-4Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET205
53002-2100-5Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2100SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 5 package rows20230609_a56a7056-c72a-4e25-9c41-327f429e7af0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNa56a7056-c72a-4e25-9c41-327f429e7af05
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDa56a7056-c72a-4e25-9c41-327f429e7af05
198335SMX 800 MG / TMP 160 MG Oral TabletSYa56a7056-c72a-4e25-9c41-327f429e7af05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2100-1530022100016 TABLET in 1 BOTTLE (53002-2100-1) 6 tablet2017-10-010000-00-00NoNoCurrent
53002-2100-25300221000210 TABLET in 1 BOTTLE (53002-2100-2) 10 tablet2017-10-010000-00-00NoNoCurrent
53002-2100-35300221000314 TABLET in 1 BOTTLE (53002-2100-3) 14 tablet2017-10-010000-00-00NoNoCurrent
53002-2100-45300221000420 TABLET in 1 BOTTLE (53002-2100-4) 20 tablet2017-10-010000-00-00NoNoCurrent
53002-2100-55300221000528 TABLET in 1 BOTTLE (53002-2100-5) 28 tablet2017-10-010000-00-00NoNoCurrent