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United States · US · US:0069-1975_67f1031d-c298-4cf9-9051-bb8f99e56442

Vyndaqel

In shortageOrange BookUNIISPLATC N07XX08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeN07XX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0069197540
    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)

Annotations

UNII (FDA Substance ID)
ZU7CF08A1A
TAFAMIDIS MEGLUMINE
RxCUI 1727003
Orange Book
N211996
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Tafamidis Meglumine Capsule
Raw payload (JSON)
{
  "unii": {
    "unii": "ZU7CF08A1A",
    "rxcui": "1727003",
    "inchikey": "DQJDBUPLRMRBAB-WZTVWXICSA-N",
    "display_name": "TAFAMIDIS MEGLUMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1b4121ee-a733-4456-a917-be2603477839": {
      "match": "brand_token",
      "title": "VYNDAQEL (TAFAMIDIS MEGLUMINE) CAPSULE, LIQUID FILLED VYNDAMAX (TAFAMIDIS) CAPSULE, LIQUID FILLED [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "15",
      "published_date": "2026-05-13"
    }
  },
  "productid": "0069-1975_67f1031d-c298-4cf9-9051-bb8f99e56442",
  "productndc": "0069-1975",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "211996",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "May 3, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAFAMIDIS MEGLUMINE",
  "shortage_reason": "Tafamidis Meglumine Capsule",
  "shortage_status": "current",
  "proprietary_name": "Vyndaqel",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA211996",
  "marketing_category": "NDA",
  "nonproprietary_name": "tafamidis meglumine",
  "start_marketing_date": "20190516",
  "active_numerator_strength": "20"
}

Related drugs

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