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United States · US · US:0574-2067_2da3b881-d6b1-4996-889b-cd882108af38

Evamist

Orange BookUNIISPLATC G03CA03

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

Identification

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

Packs · 2

  • ndc11
    0574206700
    56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-00)
  • ndc11
    0574206727
    56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-27)

Annotations

UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
N022014
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": "TRANSDERMAL",
  "spl_meta": {
    "9a0aa631-133d-406b-9d32-8a1a99af4e50": {
      "match": "brand_token",
      "title": "EVAMIST (ESTRADIOL) SPRAY [PADAGIS US LLC]",
      "spl_version": "9",
      "published_date": "2024-11-01"
    }
  },
  "productid": "0574-2067_2da3b881-d6b1-4996-889b-cd882108af38",
  "productndc": "0574-2067",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "022014",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.53MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jul 27, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Evamist",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022014",
  "marketing_category": "NDA",
  "nonproprietary_name": "Estradiol",
  "start_marketing_date": "20150411",
  "active_numerator_strength": "1.53"
}

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