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United States · US · US:0008-1123_3b6b80ea-b8f1-4a40-bd09-0fc3ff88b498

Duavee

Orange BookUNIISPLATC G03XC

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

Identification

ManufacturerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
CountryUS (United States)
ATC codeG03XC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0008112312
    1 POUCH in 1 CARTON (0008-1123-12) / 2 BLISTER PACK in 1 POUCH / 15 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
J70472UD3D
BAZEDOXIFENE ACETATE
RxCUI 1442171
Orange Book
N022247
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "J70472UD3D",
    "rxcui": "1442171",
    "inchikey": "OMZAMQFQZMUNTP-UHFFFAOYSA-N",
    "display_name": "BAZEDOXIFENE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e16705d8-4472-4f83-96ac-69fa2be066cb": {
      "match": "brand_token",
      "title": "DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]",
      "spl_version": "12",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0008-1123_3b6b80ea-b8f1-4a40-bd09-0fc3ff88b498",
  "productndc": "0008-1123",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022247",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE;0.45MG",
        "product_no": "001",
        "approval_date": "Oct 3, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED",
  "proprietary_name": "Duavee",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022247",
  "marketing_category": "NDA",
  "nonproprietary_name": "conjugated estrogens/bazedoxifene",
  "start_marketing_date": "20131003",
  "active_numerator_strength": "20; .45"
}

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