Estradiol

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerTrigen Laboratories, LLC

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1381109432
30 PACKET in 1 CARTON (13811-094-32) / 1.25 g in 1 PACKET

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

N022038

ABABABABAB

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": "13811-094_248c5ced-1972-443a-8cb0-de1e9ab011be",
  "productndc": "13811-094",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "022038",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1% (0.25GM/PACKET)",
        "product_no": "001",
        "approval_date": "Jun 4, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1% (0.5GM/PACKET)",
        "product_no": "002",
        "approval_date": "Jun 4, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1% (1GM/PACKET)",
        "product_no": "003",
        "approval_date": "Jun 4, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1% (0.75GM/PACKET)",
        "product_no": "004",
        "approval_date": "Aug 17, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1% (1.25GM/PACKET)",
        "product_no": "005",
        "approval_date": "Dec 12, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Estradiol",
  "active_ingred_unit": "mg/1.25g",
  "application_number": "NDA022038",
  "marketing_category": "NDA",
  "nonproprietary_name": "Estradiol",
  "start_marketing_date": "20221010",
  "active_numerator_strength": "1.25"
}

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