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United States · US · US:50090-2321_d0bdce5c-be19-4bfa-bc55-9682f516ea87

ESTRACE

Orange BookUNIISPLATC G03CA03

Last synced from FDA National Drug Code directory (United States) on

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
    5009023210
    1 TUBE in 1 CARTON (50090-2321-0) / 42.5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A086069
AB
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": "VAGINAL",
  "spl_meta": {
    "dfc41fcd-c5ba-4b25-b647-cf04d3988b3e": {
      "match": "brand_token",
      "title": "ESTRACE (ESTRADIOL) CREAM [ALLERGAN, INC.]",
      "spl_version": "25",
      "published_date": "2024-11-05"
    }
  },
  "productid": "50090-2321_d0bdce5c-be19-4bfa-bc55-9682f516ea87",
  "productndc": "50090-2321",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "086069",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.01%",
        "product_no": "001",
        "approval_date": "Jan 31, 1984"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "ESTRACE",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA086069",
  "marketing_category": "ANDA",
  "nonproprietary_name": "estradiol",
  "start_marketing_date": "20010701",
  "active_numerator_strength": ".1"
}

Related drugs

Other records sharing ATC code G03CA03.

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