VELTASSA
These highlights do not include all the information needed to use VELTASSA safely and effectively. See full prescribing information for VELTASSA. VELTASSA (patiromer) for oral suspensionInitial U.S. Approval: 2015
Approved
Approval ID
bf002984-d6c9-46df-aecb-a07733f763c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
Vifor Pharma, Inc.
DUNS: 808446087
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
patiromer
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53436-252
Application NumberNDA205739
Product Classification
M
Marketing Category
C73594
G
Generic Name
patiromer
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (2)
patiromerActive
Quantity: 25.2 g in 1 1
Code: 1FQ2RY5YHH
Classification: ACTIM
xanthan gumInactive
Quantity: 0.36 g in 1 1
Code: TTV12P4NEE
Classification: IACT
patiromer
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53436-084
Application NumberNDA205739
Product Classification
M
Marketing Category
C73594
G
Generic Name
patiromer
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (2)
patiromerActive
Quantity: 8.4 g in 1 1
Code: 1FQ2RY5YHH
Classification: ACTIM
xanthan gumInactive
Quantity: 0.12 g in 1 1
Code: TTV12P4NEE
Classification: IACT
patiromer
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53436-168
Application NumberNDA205739
Product Classification
M
Marketing Category
C73594
G
Generic Name
patiromer
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (2)
patiromerActive
Quantity: 16.8 g in 1 1
Code: 1FQ2RY5YHH
Classification: ACTIM
xanthan gumInactive
Quantity: 0.24 g in 1 1
Code: TTV12P4NEE
Classification: IACT