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United States · US · US:50090-6811_ab2b5194-470c-41f2-81be-25d9ade08b27

Estradiol Vaginal

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
    5009068110
    1 TUBE in 1 CARTON (50090-6811-0) / 42.5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A212313
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": {
    "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": "50090-6811_ab2b5194-470c-41f2-81be-25d9ade08b27",
  "productndc": "50090-6811",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "212313",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.01%",
        "product_no": "001",
        "approval_date": "Jul 15, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Estradiol Vaginal",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA212313",
  "marketing_category": "ANDA",
  "nonproprietary_name": "estradiol",
  "start_marketing_date": "20211001",
  "active_numerator_strength": ".1"
}

Related drugs

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