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United States · US · US:63539-122_a4742fb6-def5-49d6-965e-7990e483af6e

Duavee

Orange BookUNIISPLATC G03XC

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

Identification

ManufacturerU.S. Pharmaceuticals
CountryUS (United States)
ATC codeG03XC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6353912207
    1 BLISTER PACK in 1 CARTON (63539-122-07) / 7 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": "63539-122_a4742fb6-def5-49d6-965e-7990e483af6e",
  "productndc": "63539-122",
  "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": "20131115",
  "active_numerator_strength": "20; .45"
}

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