Imvexxy

Orange BookUNIISPLATC G03CA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMayne Pharma

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6830874800
1 BLISTER PACK in 1 CARTON (68308-748-00) / 2 INSERT in 1 BLISTER PACK
ndc11
6830874808
1 BLISTER PACK in 1 CARTON (68308-748-08) / 8 INSERT in 1 BLISTER PACK
ndc11
6830874818
1 BLISTER PACK in 1 CARTON (68308-748-18) / 18 INSERT in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

N208564

ABAB

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": {
    "104be9f2-a8f6-430e-9e01-2ee7cc1861f1": {
      "match": "brand_token",
      "title": "IMVEXXY (ESTRADIOL) INSERT [MAYNE PHARMA LLC]",
      "spl_version": "13",
      "published_date": "2025-09-18"
    }
  },
  "productid": "68308-748_6f39160a-1005-43a1-af4c-e9a26e6089ba",
  "productndc": "68308-748",
  "dosage_form": "INSERT",
  "orange_book": {
    "appl_no": "208564",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.004MG",
        "product_no": "001",
        "approval_date": "May 29, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.01MG",
        "product_no": "002",
        "approval_date": "May 29, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Imvexxy",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA208564",
  "marketing_category": "NDA",
  "nonproprietary_name": "estradiol",
  "start_marketing_date": "20231215",
  "active_numerator_strength": "10"
}

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