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United States · US · US:51655-227_48d2b826-1073-066f-e063-6394a90a2475

Estradiol

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerNorthwind Health Company, LLC
CountryUS (United States)
ATC codeG03CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5165522726
    90 TABLET in 1 BOTTLE, PLASTIC (51655-227-26)
  • ndc11
    5165522752
    30 TABLET in 1 BOTTLE, PLASTIC (51655-227-52)

Annotations

UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A040197
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4TI98Z838E",
    "rxcui": "4083",
    "inchikey": "VOXZDWNPVJITMN-ZBRFXRBCSA-N",
    "display_name": "ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "51655-227_48d2b826-1073-066f-e063-6394a90a2475",
  "productndc": "51655-227",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040197",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Oct 22, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Oct 22, 1997"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Oct 22, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Estradiol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040197",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estradiol",
  "start_marketing_date": "20230215",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code G03CA03.

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