DOTTI

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
6516299708
8 POUCH in 1 CARTON (65162-997-08) / 1 d in 1 POUCH (65162-997-04)

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

A211293

AB1AB1AB1AB1AB1

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": {
    "779751dc-243a-4dc2-ae67-3669f196b205": {
      "match": "brand_token",
      "title": "DOTTI (ESTRADIOL) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2024-08-30"
    }
  },
  "productid": "65162-997_d26f45d5-79c5-429a-bb0f-44c58fa0b569",
  "productndc": "65162-997",
  "dosage_form": "PATCH, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211293",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.025MG/24HR",
        "product_no": "001",
        "approval_date": "Feb 4, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.0375MG/24HR",
        "product_no": "002",
        "approval_date": "Feb 4, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.05MG/24HR",
        "product_no": "003",
        "approval_date": "Feb 4, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.075MG/24HR",
        "product_no": "004",
        "approval_date": "Feb 4, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.1MG/24HR",
        "product_no": "005",
        "approval_date": "Feb 4, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "DOTTI",
  "active_ingred_unit": "mg/d",
  "application_number": "ANDA211293",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estradiol",
  "start_marketing_date": "20190204",
  "active_numerator_strength": ".1"
}

Related drugs

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