VYNDAQEL- tafamidis meglumine capsule 
Pfizer Labs Division of Pfizer Inc.

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Vyndaqel®

PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton

Vyndaqel® 20 mg

tafamidis meglumina

Pfizer

PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack

Vyndaqel® 20 mg

tafamidis meglumina
Pfizer

PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack
VYNDAQEL 
tafamidis meglumine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0069-8729
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TAFAMIDIS MEGLUMINE (UNII: ZU7CF08A1A) (TAFAMIDIS - UNII:8FG9H9D31J) TAFAMIDIS MEGLUMINE20 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code VYN20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0069-8729-551 in 1 CARTON12/15/2015
130 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EXPORT ONLY12/15/2015
Labeler - Pfizer Labs Division of Pfizer Inc. (134489525)
Establishment
NameAddressID/FEIBusiness Operations
DELMAR CHEMICALS INC245906755API MANUFACTURE(0069-8729)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Pharma Solutions, LLC051762268ANALYSIS(0069-8729) , MANUFACTURE(0069-8729)
Establishment
NameAddressID/FEIBusiness Operations
AndersonBrecon Inc.053217022LABEL(0069-8729) , PACK(0069-8729)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Micron Technologies, Inc.015966157PARTICLE SIZE REDUCTION(0069-8729)

Revised: 1/2016
Document Id: b3d7bf76-c08e-4680-bec9-9fa311576ba3
Set id: 417238d2-98dd-47b4-95c5-5c06dc3702dc
Version: 3
Effective Time: 20160113
 
Pfizer Labs Division of Pfizer Inc.