Minivelle

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerNoven Therapeutics, LLC

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6896866758
8 POUCH in 1 PACKET (68968-6675-8) / 1 d in 1 POUCH

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

N203752

AB3AB3AB3AB3AB3

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": {
    "6c5c47ab-28ee-11e1-bfc2-0800200c9a66": {
      "match": "brand_token",
      "title": "MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]",
      "spl_version": "19",
      "published_date": "2024-02-27"
    }
  },
  "productid": "68968-6675_58e55d14-a9df-4814-9b60-b7c9ce37b0b7",
  "productndc": "68968-6675",
  "dosage_form": "FILM, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203752",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.0375MG/24HR",
        "product_no": "001",
        "approval_date": "Oct 29, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.075MG/24HR",
        "product_no": "002",
        "approval_date": "Oct 29, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.05MG/24HR",
        "product_no": "003",
        "approval_date": "Oct 29, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.1MG/24HR",
        "product_no": "004",
        "approval_date": "Oct 29, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.025MG/24HR",
        "product_no": "005",
        "approval_date": "Sep 23, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Minivelle",
  "active_ingred_unit": "mg/d",
  "application_number": "NDA203752",
  "marketing_category": "NDA",
  "nonproprietary_name": "estradiol",
  "start_marketing_date": "20121220",
  "active_numerator_strength": ".075"
}

Related drugs

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