Depo-Estradiol

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerPharmacia & Upjohn Company LLC

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0009027101
1 VIAL in 1 CARTON (0009-0271-01) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

7E1DV054LO

ESTRADIOL CYPIONATE

RxCUI 1000146

Orange Book

A085470

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "7E1DV054LO",
    "rxcui": "1000146",
    "inchikey": "UOACKFBJUYNSLK-XRKIENNPSA-N",
    "display_name": "ESTRADIOL CYPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "9a4229fd-fecd-4ac1-9c4f-6d442533457f": {
      "match": "brand_token",
      "title": "DEPO-ESTRADIOL (ESTRADIOL CYPIONATE) INJECTION [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "9",
      "published_date": "2024-02-29"
    }
  },
  "productid": "0009-0271_70957ffe-7710-4a3a-98fa-bf5d84f38ddb",
  "productndc": "0009-0271",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "085470",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "3MG/ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "5MG/ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL CYPIONATE",
  "proprietary_name": "Depo-Estradiol",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA085470",
  "marketing_category": "ANDA",
  "nonproprietary_name": "estradiol cypionate",
  "start_marketing_date": "19790815",
  "active_numerator_strength": "5"
}

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