Estradiol

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6923824513
30 PACKET in 1 CARTON (69238-2451-3) / .5 g in 1 PACKET (69238-2451-1)

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

A216055

ABABABABAB

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": "TOPICAL",
  "spl_meta": {
    "50c786d6-91bd-4eea-9455-ff2abc08372f": {
      "match": "brand_token",
      "title": "ESTRADIOL AND NORETHINDRONE ACETATE TABLET [INGENUS PHARMACEUTICALS, LLC]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "69238-2451_cebb61d3-34b7-44a7-aae7-d23e21651713",
  "productndc": "69238-2451",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "216055",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1% (0.25GM/PACKET)",
        "product_no": "001",
        "approval_date": "Jul 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1% (0.5GM/PACKET)",
        "product_no": "002",
        "approval_date": "Jul 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1% (0.75GM/PACKET)",
        "product_no": "003",
        "approval_date": "Jul 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1% (1GM/PACKET)",
        "product_no": "004",
        "approval_date": "Jul 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1% (1.25GM/PACKET)",
        "product_no": "005",
        "approval_date": "Jul 12, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "Estradiol",
  "active_ingred_unit": "mg/.5g",
  "application_number": "ANDA216055",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estradiol Transdermal",
  "start_marketing_date": "20240715",
  "active_numerator_strength": ".5"
}

Related drugs

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