ESTRADIOL

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6807144851
120 TABLET in 1 BOTTLE (68071-4485-1)
ndc11
6807144853
30 TABLET in 1 BOTTLE (68071-4485-3)
ndc11
6807144856
60 TABLET in 1 BOTTLE (68071-4485-6)
ndc11
6807144859
90 TABLET in 1 BOTTLE (68071-4485-9)

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

A040275

ABABAB

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": "ORAL",
  "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": "68071-4485_1a8d82ad-fcde-755b-e063-6394a90a3575",
  "productndc": "68071-4485",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040275",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Dec 29, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Dec 29, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Dec 29, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "ESTRADIOL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040275",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ESTRADIOL",
  "start_marketing_date": "20170410",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code G03CA03.

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