VYNDAQEL- tafamidis meglumine capsule

Vyndaqel by

Drug Labeling and Warnings

Vyndaqel by is a Prescription medication manufactured, distributed, or labeled by Pfizer Labs Division of Pfizer Inc., DELMAR CHEMICALS INC, Catalent Pharma Solutions, LLC, AndersonBrecon Inc., Catalent Micron Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton

Vyndaqel® 20 mg

tafamidis meglumina

Pfizer

PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack

Vyndaqel® 20 mg

tafamidis meglumina
Pfizer

INGREDIENTS AND APPEARANCE

VYNDAQEL 
tafamidis meglumine capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0069-8729
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TAFAMIDIS MEGLUMINE (UNII: ZU7CF08A1A) (TAFAMIDIS - UNII:8FG9H9D31J)	TAFAMIDIS MEGLUMINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	VYN20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0069-8729-55	1 in 1 CARTON	12/15/2015
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXPORT ONLY		12/15/2015

Labeler - Pfizer Labs Division of Pfizer Inc. (134489525)

Establishment
Name	Address	ID/FEI	Business Operations
DELMAR CHEMICALS INC		245906755	API MANUFACTURE(0069-8729)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Pharma Solutions, LLC		051762268	ANALYSIS(0069-8729) , MANUFACTURE(0069-8729)

Establishment
Name	Address	ID/FEI	Business Operations
AndersonBrecon Inc.		053217022	LABEL(0069-8729) , PACK(0069-8729)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Micron Technologies, Inc.		015966157	PARTICLE SIZE REDUCTION(0069-8729)