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
0378335099
4 POUCH in 1 CARTON (0378-3350-99) / 1 PATCH in 1 POUCH (0378-3350-16) / 7 d in 1 PATCH

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

A075182

AB2AB2AB2AB2AB2AB2

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": "0378-3350_49f22eba-c5a4-4264-b905-6a8ff7e0d884",
  "productndc": "0378-3350",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "075182",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "0.1MG/24HR",
        "product_no": "001",
        "approval_date": "Feb 24, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "0.075MG/24HR",
        "product_no": "002",
        "approval_date": "Jan 26, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "0.025MG/24HR",
        "product_no": "003",
        "approval_date": "Jan 26, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "0.0375MG/24HR",
        "product_no": "004",
        "approval_date": "Jul 20, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "0.06MG/24HR",
        "product_no": "005",
        "approval_date": "Jul 20, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "0.05MG/24HR",
        "product_no": "006",
        "approval_date": "Feb 24, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Estradiol",
  "active_ingred_unit": "mg/d",
  "application_number": "ANDA075182",
  "marketing_category": "ANDA",
  "nonproprietary_name": "estradiol",
  "start_marketing_date": "20000301",
  "active_numerator_strength": ".05"
}

Related drugs

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