EstroGel

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerASCEND Therapeutics US, LLC

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1713961740
50 g in 1 BOTTLE, PUMP (17139-617-40)

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

N021166

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": {
    "762ac371-bb8b-47e7-b48f-e80d452c9dd4": {
      "match": "brand_token",
      "title": "ESTROGEL (ESTRADIOL) GEL, METERED [ASCEND THERAPEUTICS US, LLC]",
      "spl_version": "55",
      "published_date": "2026-06-01"
    }
  },
  "productid": "17139-617_55240d4b-c38e-43ed-9d58-a9f5d453d2c2",
  "productndc": "17139-617",
  "dosage_form": "GEL, METERED",
  "orange_book": {
    "appl_no": "021166",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.06%",
        "product_no": "001",
        "approval_date": "Feb 9, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.06% (1.25GM/ACTIVATION)",
        "product_no": "002",
        "approval_date": "Feb 9, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "EstroGel",
  "active_ingred_unit": "mg/1.25g",
  "application_number": "NDA021166",
  "marketing_category": "NDA",
  "nonproprietary_name": "estradiol",
  "start_marketing_date": "20040209",
  "active_numerator_strength": ".75"
}

Related drugs

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