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 ID: 0069-1975_013d062d-5786-4f73-9d50-98476f9b478d
• NDC: 0069-1975
• Product Type: Human Prescription Drug
• Proprietary Name: Vyndaqel
• Generic Name: Tafamidis Meglumine
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-16
• Marketing Category: NDA / NDA
• Application Number: NDA211996
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: TAFAMIDIS MEGLUMINE
• Active Ingredient Strength: 20 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

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 Date: 2019-05-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-1975-40 [00069197540]

Vyndaqel CAPSULE, LIQUID FILLED

• Marketing Category: NDA
• Application Number: NDA211996
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-16

NDC 0069-1975-12 [00069197512]

Vyndaqel CAPSULE, LIQUID FILLED

• Marketing Category: NDA
• Application Number: NDA211996
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-16

Drug Details

Active Ingredients

Ingredient	Strength
TAFAMIDIS MEGLUMINE	20 mg/1

OpenFDA Data

• SPL SET ID: 1b4121ee-a733-4456-a917-be2603477839
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • ZU7CF08A1A
  • 8FG9H9D31J
• RxNorm Concept Unique ID - RxCUI:
  • 2168534
  • 2168548
  • 2168540
  • 2168542