Vyndaqel
These highlights do not include all the information needed to use VYNDAQEL and VYNDAMAX safely and effectively. See full prescribing information for VYNDAQEL and VYNDAMAX. VYNDAQEL (tafamidis meglumine) capsules, for oral administration Initial U.S. Approval: 2019 VYNDAMAX™ (tafamidis) capsules, for oral administration Initial U.S. Approval: 2019
Approved
Approval ID
1b4121ee-a733-4456-a917-be2603477839
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tafamidis
PRODUCT DETAILS
NDC Product Code0069-8730
Application NumberNDA212161
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 1, 2023
Generic Nametafamidis
INGREDIENTS (13)
TAFAMIDISActive
Quantity: 61 mg in 1 1
Code: 8FG9H9D31J
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
tafamidis meglumine
PRODUCT DETAILS
NDC Product Code0069-1975
Application NumberNDA211996
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 1, 2023
Generic Nametafamidis meglumine
INGREDIENTS (14)
TAFAMIDIS MEGLUMINEActive
Quantity: 20 mg in 1 1
Code: ZU7CF08A1A
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PIGMENT RED 48Inactive
Code: 07XHK4SAV6
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT