vyndaqel

Generic: tafamidis meglumine

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vyndaqel
Generic Name tafamidis meglumine
Labeler pfizer laboratories div pfizer inc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

tafamidis meglumine 20 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-1975
Product ID 0069-1975_4ee63a96-9d81-4941-a641-510beb6abb81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211996
Marketing Start 2019-05-16
Marketing End 2027-07-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00691975
Hyphenated Format 0069-1975

Supplemental Identifiers

RxCUI
2168534 2168540 2168542 2168548
UNII
ZU7CF08A1A 8FG9H9D31J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vyndaqel (source: ndc)
Generic Name tafamidis meglumine (source: ndc)
Application Number NDA211996 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 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)
source: ndc

Packages (1)

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)

Ingredients (1)

tafamidis meglumine (20 mg/1)

Linked Drug Pages (1)

Vyndaqel, Vyndamax ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4ee63a96-9d81-4941-a641-510beb6abb81", "openfda": {"unii": ["ZU7CF08A1A", "8FG9H9D31J"], "rxcui": ["2168534", "2168540", "2168542", "2168548"], "spl_set_id": ["1b4121ee-a733-4456-a917-be2603477839"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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)", "package_ndc": "0069-1975-40", "marketing_end_date": "20270731", "marketing_start_date": "20190516"}], "brand_name": "Vyndaqel", "product_id": "0069-1975_4ee63a96-9d81-4941-a641-510beb6abb81", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "0069-1975", "generic_name": "tafamidis meglumine", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vyndaqel", "active_ingredients": [{"name": "TAFAMIDIS MEGLUMINE", "strength": "20 mg/1"}], "application_number": "NDA211996", "marketing_category": "NDA", "marketing_end_date": "20270731", "marketing_start_date": "20190516"}