FDA.reportPublic FDA data

ARBLI

Product NDC
83245-053
11-digit product format
832450053
Labeler code
83245
Product ID
83245-053_0d6183d3-e8e3-416e-a359-9348c61ac736
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium
Dosage form
SUSPENSION
Route
ORAL
Labeler
Scienture LLC
Application
NDA218772
Marketing category
NDA
Marketing start
2025-03-19
Substance
LOSARTAN POTASSIUM
Active strength
10 mg/mL
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ARBLI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A
Rxcui2709039, 2709046

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83245-053-062025-03-20C16284748780-12cef2736-6e0d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ARBLI safely and effectively. See full prescribing information for ARBLI. ARBLI (losartan potassium) oral suspension, for oral use Initial U.S. Approval: 1995
83245-053-062025-03-20C16284748780-12cef2736-6e0d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ARBLI safely and effectively. See full prescribing information for ARBLI. ARBLI (losartan potassium) oral suspension, for oral use Initial U.S. Approval: 1995
83245-053-062025-01-30C16284748780-12cef2736-6e0d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ARBLI safely and effectively. See full prescribing information for ARBLI. ARBLI (losartan potassium) oral suspension, for oral use Initial U.S. Approval: 1995
83245-053-062025-01-30C16284748780-12cef2736-6e0d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ARBLI safely and effectively. See full prescribing information for ARBLI. ARBLI (losartan potassium) oral suspension, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83245-053-06ARBLI1 in 1 CARTONSUSPENSION119
83245-053-06ARBLI165 mL in 1 BOTTLESUSPENSION16519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83245-053-06ML - Milliliter83245-053115c4f96-403c-4a1f-8930-e7331acc55bd12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83245-053ARBLI (LOSARTAN POTASSIUM) SUSPENSION [SCIENTURE LLC]18Current NDC, 2 package rows20250406_afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709046Arbli 10 MG/mL Oral SuspensionPSNafd2d1ba-e7af-4e4e-8b7e-a9f72612fc9719
2709039losartan potassium 10 MG/mL Oral SuspensionPSNafd2d1ba-e7af-4e4e-8b7e-a9f72612fc9719
2709046losartan potassium 10 MG/ML Oral Suspension [Arbli]SBDafd2d1ba-e7af-4e4e-8b7e-a9f72612fc9719
2709039losartan potassium 10 MG/ML Oral SuspensionSCDafd2d1ba-e7af-4e4e-8b7e-a9f72612fc9719
2709046Arbli 10 MG (equivalent to losartan 9.2 MG) per 1 mL Oral SuspensionSYafd2d1ba-e7af-4e4e-8b7e-a9f72612fc9719
2709039losartan K+ 10 MG/ML Oral SuspensionSYafd2d1ba-e7af-4e4e-8b7e-a9f72612fc9719
2709046losartan K+ 10 MG/ML Oral Suspension [Arbli]SYafd2d1ba-e7af-4e4e-8b7e-a9f72612fc9719
2709039losartan Pot 10 MG/ML Oral SuspensionSYafd2d1ba-e7af-4e4e-8b7e-a9f72612fc9719
2709046losartan Pot 10 MG/ML Oral Suspension [Arbli]SYafd2d1ba-e7af-4e4e-8b7e-a9f72612fc9719
2709039losartan potassium 10 MG (equivalent to losartan 9.2 MG) per 1 mL Oral SuspensionSYafd2d1ba-e7af-4e4e-8b7e-a9f72612fc9719

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83245-053-06832450053061 BOTTLE in 1 CARTON (83245-053-06) / 165 mL in 1 BOTTLE1 bottle2025-03-19NoNoHistorical