Estradiol

Orange BookUNIISPLATC G03CA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378461926
8 POUCH in 1 CARTON (0378-4619-26) / 1 PATCH in 1 POUCH (0378-4619-16) / 3.5 d in 1 PATCH

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

A206685

AB3AB3AB3AB3AB3

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": "TRANSDERMAL",
  "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": "0378-4619_e3b94477-b715-40f6-bbbb-fe52a87148dd",
  "productndc": "0378-4619",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "206685",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.025MG/24HR",
        "product_no": "001",
        "approval_date": "Aug 15, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.0375MG/24HR",
        "product_no": "002",
        "approval_date": "Aug 15, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.05MG/24HR",
        "product_no": "003",
        "approval_date": "Aug 15, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.075MG/24HR",
        "product_no": "004",
        "approval_date": "Aug 15, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.1MG/24HR",
        "product_no": "005",
        "approval_date": "Aug 15, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Estradiol",
  "active_ingred_unit": "mg/d",
  "application_number": "ANDA206685",
  "marketing_category": "ANDA",
  "nonproprietary_name": "estradiol",
  "start_marketing_date": "20181101",
  "active_numerator_strength": ".025"
}

Related drugs

Other records sharing ATC code G03CA03.

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