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United States · US · US:63629-8713_06e2b88b-16e5-4926-bc67-7ca1c1f9156f

Estradiol

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG03CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362987131
    1 TUBE, WITH APPLICATOR in 1 CARTON (63629-8713-1) / 42.5 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
CXY7B3Q98Z
ESTRADIOL HEMIHYDRATE
RxCUI 236859
Orange Book
A209767
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "CXY7B3Q98Z",
    "rxcui": "236859",
    "inchikey": "ZVVGLAMWAQMPDR-WVEWYJOQSA-N",
    "display_name": "ESTRADIOL HEMIHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "50c786d6-91bd-4eea-9455-ff2abc08372f": {
      "match": "brand_token",
      "title": "ESTRADIOL AND NORETHINDRONE ACETATE TABLET [INGENUS PHARMACEUTICALS, LLC]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "63629-8713_06e2b88b-16e5-4926-bc67-7ca1c1f9156f",
  "productndc": "63629-8713",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "209767",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.01%",
        "product_no": "001",
        "approval_date": "Mar 5, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL HEMIHYDRATE",
  "proprietary_name": "Estradiol",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA209767",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estradiol",
  "start_marketing_date": "20180305",
  "active_numerator_strength": ".1"
}

Related drugs

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