FDA.reportPublic FDA data

Sulfameth/Trimeth-DS

Product NDC
61919-645
11-digit product format
619190645
Labeler code
61919
Product ID
61919-645_47e154aa-d636-469b-e063-6394a90ad9b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfameth/Trimeth-DS
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090624
Marketing category
ANDA
Marketing start
2019-08-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfameth/Trimeth-DS
Listing expiration
2027-12-31

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
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-645-022025-01-30C16284748780-12cef2736-9504-d83d-e063-dadaa90ab31fSulfameth/Trimeth-DS
61919-645-102025-01-30C16284748780-12cef2736-7750-d83d-e063-dadaa90ab31fSulfameth/Trimeth-DS
61919-645-142025-01-30C16284748780-12cef2736-68fc-d83d-e063-dadaa90ab31fSulfameth/Trimeth-DS
61919-645-202025-01-30C16284748780-12cef2736-7e6f-d83d-e063-dadaa90ab31fSULFAMETH/TRIMETH DS
61919-645-282025-01-30C16284748780-12cef2736-8f50-d83d-e063-dadaa90ab31fSULFAMETH/TRIMETH-DS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-645-06Sulfameth/Trimeth-DS6 in 1 BOTTLETABLET67
61919-645-30Sulfameth/Trimeth-DS30 in 1 BOTTLETABLET307
61919-645-56Sulfameth/Trimeth-DS56 in 1 BOTTLETABLET567
61919-645-60Sulfameth/Trimeth-DS60 in 1 BOTTLETABLET607
61919-645-02Sulfameth/Trimeth-DS2 in 1 BOTTLETABLET21
61919-645-10Sulfameth/Trimeth-DS10 in 1 BOTTLETABLET101
61919-645-14Sulfameth/Trimeth-DS14 in 1 BOTTLETABLET141
61919-645-20SULFAMETH/TRIMETH-DS20 in 1 BOTTLETABLET201
61919-645-28SULFAMETH/TRIMETH-DS28 in 1 BOTTLETABLET281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-645-02EA - Each61919-645bf3b9bdf-91fe-4aa7-9488-deb0c54dd1a512019-08-06
61919-645-10EA - Each61919-6451d27bf1a-3602-44eb-977a-6e39d869472912019-08-06
61919-645-14EA - Each61919-645e97cad26-5750-460b-9180-62e2584d90d612019-09-05
61919-645-20EA - Each61919-645b0b61e65-fc68-48e5-96e2-b2f8f783df9d12019-05-02
61919-645-28EA - Each61919-64516c2b04e-8277-4abe-afe0-6dfe33dc743912019-09-05
61919-645-56EA - Each61919-64591673680-56ce-4ba6-a230-6f99b656ca9112022-06-06
61919-645-60EA - Each61919-645cf6adc0f-6cc9-4ac1-b6ef-6d3ba78f563812019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-645SULFAMETH/TRIMETH-DS TABLET [DIRECT_RX]6Current NDC, Legacy NDC, 4 package rows20240402_90026ce8-3305-6272-e053-2995a90a57e0.zip
61919-645SULFAMETH/TRIMETH-DS TABLET [DIRECT RX]1Current NDC, Legacy NDC, 1 package rows20190117_7cc4029e-5f4b-880a-e053-2991aa0a3264.zip
61919-645SULFAMETH/TRIMETH-DS TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190703_8cb4ed51-aa27-f6e6-e053-2a95a90a7df5.zip
61919-645SULFAMETH/TRIMETH-DS TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190720_8de58d77-c631-2b9d-e053-2995a90a54ea.zip
61919-645SULFAMETH/TRIMETH-DS TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190806_8f72fca6-7dba-641f-e053-2a95a90ad148.zip
61919-645SULFAMETH/TRIMETH-DS TABLET [DIRECTRX]1Current NDC, Legacy NDC, 1 package rows20190423_87240462-3840-5045-e053-2991aa0a4341.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN90026ce8-3305-6272-e053-2995a90a57e07
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD90026ce8-3305-6272-e053-2995a90a57e07
198335SMX 800 MG / TMP 160 MG Oral TabletSY90026ce8-3305-6272-e053-2995a90a57e07
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN7cc4029e-5f4b-880a-e053-2991aa0a32641
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN87240462-3840-5045-e053-2991aa0a43411
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN8f72fca6-7dba-641f-e053-2a95a90ad1481
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN8cb4ed51-aa27-f6e6-e053-2a95a90a7df51
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN8de58d77-c631-2b9d-e053-2995a90a54ea1
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD7cc4029e-5f4b-880a-e053-2991aa0a32641
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD8f72fca6-7dba-641f-e053-2a95a90ad1481
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD8de58d77-c631-2b9d-e053-2995a90a54ea1
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD8cb4ed51-aa27-f6e6-e053-2a95a90a7df51
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD87240462-3840-5045-e053-2991aa0a43411
198335SMX 800 MG / TMP 160 MG Oral TabletSY8de58d77-c631-2b9d-e053-2995a90a54ea1
198335SMX 800 MG / TMP 160 MG Oral TabletSY8f72fca6-7dba-641f-e053-2a95a90ad1481
198335SMX 800 MG / TMP 160 MG Oral TabletSY8cb4ed51-aa27-f6e6-e053-2a95a90a7df51
198335SMX 800 MG / TMP 160 MG Oral TabletSY87240462-3840-5045-e053-2991aa0a43411
198335SMX 800 MG / TMP 160 MG Oral TabletSY7cc4029e-5f4b-880a-e053-2991aa0a32641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-645-02619190645022 TABLET in 1 BOTTLE (61919-645-02) 2 tablet2019-07-020000-00-00NoNoCurrent
61919-645-06619190645066 TABLET in 1 BOTTLE (61919-645-06) 6 tablet2019-08-130000-00-00NoNoCurrent
61919-645-106191906451010 TABLET in 1 BOTTLE (61919-645-10) 10 tablet2019-07-170000-00-00NoNoCurrent
61919-645-146191906451414 TABLET in 1 BOTTLE (61919-645-14) 14 tablet2019-08-060000-00-00NoNoCurrent
61919-645-206191906452020 TABLET in 1 BOTTLE (61919-645-20) 20 tablet2019-04-220000-00-00NoNoCurrent
61919-645-286191906452828 TABLET in 1 BOTTLE (61919-645-28) 28 tablet2018-12-110000-00-00NoNoCurrent
61919-645-306191906453030 TABLET in 1 BOTTLE (61919-645-30) 30 tablet2019-08-130000-00-00NoNoCurrent
61919-645-566191906455656 TABLET in 1 BOTTLE (61919-645-56) 56 tablet2019-08-130000-00-00NoNoCurrent
61919-645-606191906456060 TABLET in 1 BOTTLE (61919-645-60) 60 tablet2019-08-130000-00-00NoNoCurrent