Estradiol

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerXiromed, LLC

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7070019535
30 PACKET in 1 CARTON (70700-195-35) / 1.25 g in 1 PACKET

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

A211783

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": "TOPICAL",
  "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": "70700-195_5729f205-db48-4ed1-3b2d-190fef4ad81e",
  "productndc": "70700-195",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "211783",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1% (0.25GM/PACKET)",
        "product_no": "001",
        "approval_date": "Aug 10, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1% (0.5GM/PACKET)",
        "product_no": "002",
        "approval_date": "Aug 10, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1% (1GM/PACKET)",
        "product_no": "003",
        "approval_date": "Aug 10, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Estradiol",
  "active_ingred_unit": "mg/1.25g",
  "application_number": "ANDA211783",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estradiol Gel 0.1%",
  "start_marketing_date": "20221001",
  "active_numerator_strength": "1.25"
}

Related drugs

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