Estradiol

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009076110
4 POUCH in 1 CARTON (50090-7611-0) / 1 PATCH in 1 POUCH / 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": "50090-7611_55192761-40f5-4b70-9588-7784bf715148",
  "productndc": "50090-7611",
  "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"
}

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