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United States · US · US:66993-002_b871564a-2980-4404-a9f5-f52e3f3cecd6

Estradiol Vaginal Cream

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerPrasco Laboratories
CountryUS (United States)
ATC codeG03CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6699300210
    1 TUBE in 1 CARTON (66993-002-10) / 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": "66993-002_b871564a-2980-4404-a9f5-f52e3f3cecd6",
  "productndc": "66993-002",
  "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 Cream",
  "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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