ESTRADIOL VALERATE

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerAmerican Regent, Inc.

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0517042001
1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01) / 5 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

OKG364O896

ESTRADIOL VALERATE

RxCUI 24395

Orange Book

A090920

AOAO

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "OKG364O896",
    "rxcui": "24395",
    "inchikey": "RSEPBGGWRJCQGY-RBRWEJTLSA-N",
    "display_name": "ESTRADIOL VALERATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "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": "0517-0420_abfdb011-4fe4-4c0f-b2df-77398b47738f",
  "productndc": "0517-0420",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "090920",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "20MG/ML",
        "product_no": "001",
        "approval_date": "Jan 19, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "40MG/ML",
        "product_no": "002",
        "approval_date": "Jan 19, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL VALERATE",
  "proprietary_name": "ESTRADIOL VALERATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090920",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ESTRADIOL VALERATE",
  "start_marketing_date": "20200301",
  "active_numerator_strength": "20"
}

Related drugs

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