NDC 0069-1975

Vyndaqel

Tafamidis Meglumine

Vyndaqel is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Tafamidis Meglumine.

Product ID0069-1975_013d062d-5786-4f73-9d50-98476f9b478d
NDC0069-1975
Product TypeHuman Prescription Drug
Proprietary NameVyndaqel
Generic NameTafamidis Meglumine
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-05-16
Marketing CategoryNDA / NDA
Application NumberNDA211996
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameTAFAMIDIS MEGLUMINE
Active Ingredient Strength20 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0069-1975-40

4 CARTON in 1 CARTON (0069-1975-40) > 30 BLISTER PACK in 1 CARTON > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-1975-12)
Marketing Start Date2019-05-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-1975-40 [00069197540]

Vyndaqel CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA211996
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-16

NDC 0069-1975-12 [00069197512]

Vyndaqel CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA211996
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-16

Drug Details

Active Ingredients

IngredientStrength
TAFAMIDIS MEGLUMINE20 mg/1

OpenFDA Data

SPL SET ID:1b4121ee-a733-4456-a917-be2603477839
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2168534
  • 2168548
  • 2168540
  • 2168542

  • Trademark Results [Vyndaqel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VYNDAQEL
    VYNDAQEL
    87706835 not registered Live/Pending
    Wyeth LLC
    2017-12-04
    VYNDAQEL
    VYNDAQEL
    77955739 4106105 Live/Registered
    Wyeth LLC
    2010-03-10

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