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
5009076100
8 POUCH in 1 CARTON (50090-7610-0) / 1 d in 1 POUCH

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

N203752

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": "50090-7610_9db02f59-f5e3-42ab-8a25-a204b04a1e34",
  "productndc": "50090-7610",
  "dosage_form": "FILM, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203752",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.0375MG/24HR",
        "product_no": "001",
        "approval_date": "Oct 29, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.075MG/24HR",
        "product_no": "002",
        "approval_date": "Oct 29, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.05MG/24HR",
        "product_no": "003",
        "approval_date": "Oct 29, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.1MG/24HR",
        "product_no": "004",
        "approval_date": "Oct 29, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.025MG/24HR",
        "product_no": "005",
        "approval_date": "Sep 23, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Estradiol",
  "active_ingred_unit": "mg/d",
  "application_number": "NDA203752",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "estradiol",
  "start_marketing_date": "20180101",
  "active_numerator_strength": ".0375"
}

Related drugs

Other records sharing ATC code G03CA03.

Access this data programmatically

Query Estradiol and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs