FDA.reportPublic FDA data

VELTASSA

Product NDC
53436-084
11-digit product format
534360084
Labeler code
53436
Product ID
53436-084_3e4b6452-1c7c-4f58-aee4-12fb185aaa83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
patiromer
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Vifor Pharma, Inc.
Application
NDA205739
Marketing category
NDA
Marketing start
2015-10-23
Substance
PATIROMER
Active strength
8.4 g/1
Pharmacologic classes
Potassium Binder [EPC], Potassium Ion Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PATIROMER8.4 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1FQ2RY5YHH
Rxcui1716209, 1716215, 1716217, 1716219, 1716221, 1716223, 2692050, 2692052

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4ba40eb-1b5c-4d96-9a06-8ded1ce02126Product name220250625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53436-084-042024-08-15C16284748780-11030e365-0a48-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015
53436-084-302024-08-15C16284748780-11030e365-0a48-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015
53436-084-922024-08-15C16284748780-11030e365-0a48-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015
53436-084-042024-07-30C16284748780-11030e365-0a48-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015
53436-084-302024-07-30C16284748780-11030e365-0a48-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015
53436-084-922024-07-30C16284748780-11030e365-0a48-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015
53436-084-042024-01-30C16284748780-11030e365-0a48-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015
53436-084-302024-01-30C16284748780-11030e365-0a48-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015
53436-084-922024-01-30C16284748780-11030e365-0a48-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VELTASSA ® safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspension Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53436-084-01VELTASSA1 in 1 PACKETPOWDER, FOR SUSPENSION123
53436-084-04VELTASSA4 in 1 CARTONPOWDER, FOR SUSPENSION423
53436-084-30VELTASSA30 in 1 CARTONPOWDER, FOR SUSPENSION3023
53436-084-91VELTASSA1 in 1 PACKETPOWDER, FOR SUSPENSION123
53436-084-92VELTASSA4 in 1 CARTONPOWDER, FOR SUSPENSION423

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53436-084VELTASSA (PATIROMER) POWDER, FOR SUSPENSION [VIFOR PHARMA, INC.]23Current NDC, Legacy NDC, 5 package rows20250209_bf002984-d6c9-46df-aecb-a07733f763c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2692050patiromer 1 GM Powder for Oral SuspensionPSNbf002984-d6c9-46df-aecb-a07733f763c123
1716217patiromer 16.8 GM Powder for Oral SuspensionPSNbf002984-d6c9-46df-aecb-a07733f763c123
1716221patiromer 25.2 GM Powder for Oral SuspensionPSNbf002984-d6c9-46df-aecb-a07733f763c123
1716209patiromer 8.4 GM Powder for Oral SuspensionPSNbf002984-d6c9-46df-aecb-a07733f763c123
2692052Veltassa 1 GM Powder for Oral SuspensionPSNbf002984-d6c9-46df-aecb-a07733f763c123
1716219Veltassa 16.8 GM Powder for Oral SuspensionPSNbf002984-d6c9-46df-aecb-a07733f763c123
1716223Veltassa 25.2 GM Powder for Oral SuspensionPSNbf002984-d6c9-46df-aecb-a07733f763c123
1716215Veltassa 8.4 GM Powder for Oral SuspensionPSNbf002984-d6c9-46df-aecb-a07733f763c123
2692052patiromer 1000 MG Powder for Oral Suspension [Veltassa]SBDbf002984-d6c9-46df-aecb-a07733f763c123
1716219patiromer 16800 MG Powder for Oral Suspension [Veltassa]SBDbf002984-d6c9-46df-aecb-a07733f763c123
1716223patiromer 25200 MG Powder for Oral Suspension [Veltassa]SBDbf002984-d6c9-46df-aecb-a07733f763c123
1716215patiromer 8400 MG Powder for Oral Suspension [Veltassa]SBDbf002984-d6c9-46df-aecb-a07733f763c123
2692050patiromer 1000 MG Powder for Oral SuspensionSCDbf002984-d6c9-46df-aecb-a07733f763c123
1716217patiromer 16800 MG Powder for Oral SuspensionSCDbf002984-d6c9-46df-aecb-a07733f763c123
1716221patiromer 25200 MG Powder for Oral SuspensionSCDbf002984-d6c9-46df-aecb-a07733f763c123
1716209patiromer 8400 MG Powder for Oral SuspensionSCDbf002984-d6c9-46df-aecb-a07733f763c123
2692050patiromer 1 GM Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
1716217patiromer 16.8 GM Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
1716221patiromer 25.2 GM Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
1716209patiromer 8.4 GM Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
2692052Veltassa 1 GM Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
2692052Veltassa 1000 MG Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
1716219Veltassa 16.8 GM Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
1716219Veltassa 16800 MG Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
1716223Veltassa 25.2 GM Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
1716223Veltassa 25200 MG Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
1716215Veltassa 8.4 GM Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123
1716215Veltassa 8400 MG Powder for Oral SuspensionSYbf002984-d6c9-46df-aecb-a07733f763c123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53436-084-01534360084011 in 1 PACKETHistorical
53436-084-04534360084044 PACKET in 1 CARTON (53436-084-04) / 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-084-01) 4 packet2015-10-230000-00-00NoNoCurrent
53436-084-305343600843030 PACKET in 1 CARTON (53436-084-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-084-01) 30 packet2015-10-230000-00-00NoNoCurrent
53436-084-91534360084911 in 1 PACKETHistorical
53436-084-92534360084924 PACKET in 1 CARTON (53436-084-92) / 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-084-91) 4 packet2016-05-010000-00-00NoNoCurrent