LYLLANA

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6516215008
8 POUCH in 1 CARTON (65162-150-08) / 1 d in 1 POUCH (65162-150-04)

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

A211396

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": {
    "09c472c6-a38a-4a3d-b048-6fefd52e2ad3": {
      "match": "brand_token",
      "title": "LYLLANA (ESTRADIOL) PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "15",
      "published_date": "2024-06-07"
    }
  },
  "productid": "65162-150_6828b547-27f6-4099-981f-a8efcba66370",
  "productndc": "65162-150",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211396",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.025MG/24HR",
        "product_no": "001",
        "approval_date": "Sep 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.0375MG/24HR",
        "product_no": "002",
        "approval_date": "Sep 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.05MG/24HR",
        "product_no": "003",
        "approval_date": "Sep 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.075MG/24HR",
        "product_no": "004",
        "approval_date": "Sep 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.1MG/24HR",
        "product_no": "005",
        "approval_date": "Sep 28, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "LYLLANA",
  "active_ingred_unit": "mg/d",
  "application_number": "ANDA211396",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estradiol",
  "start_marketing_date": "20200930",
  "active_numerator_strength": ".075"
}

Related drugs

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