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United States · US · US:42291-962_48c2d001-2094-12ab-e063-6294a90a4f10

Yuvafem

Orange BookUNIISPLATC G03CA03

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

Identification

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

Packs · 2

  • ndc11
    4229196208
    8 APPLICATOR in 1 CARTON (42291-962-08) / 1 TABLET in 1 APPLICATOR (42291-962-11)
  • ndc11
    4229196218
    18 APPLICATOR in 1 CARTON (42291-962-18) / 1 TABLET in 1 APPLICATOR (42291-962-11)

Annotations

UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A205256
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": {
    "d20abc9a-8f47-e274-c9b1-b71c9489761f": {
      "match": "brand_token",
      "title": "YUVAFEM (ESTRADIOL) TABLET [AVKARE]",
      "spl_version": "9",
      "published_date": "2026-01-21"
    }
  },
  "productid": "42291-962_48c2d001-2094-12ab-e063-6294a90a4f10",
  "productndc": "42291-962",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205256",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MCG",
        "product_no": "001",
        "approval_date": "May 29, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Yuvafem",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA205256",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estradiol",
  "start_marketing_date": "20161019",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G03CA03.

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