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United States · US · US:70710-1688_b2f2e6fc-229a-46a6-ad64-02e665f8e942

FULVESTRANT

Orange BookUNIISPLATC L02BA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7071016888
    2 SYRINGE, GLASS in 1 CARTON (70710-1688-8) / 5 mL in 1 SYRINGE, GLASS (70710-1688-2)

Annotations

UNII (FDA Substance ID)
22X328QOC4
FULVESTRANT
RxCUI 282357
Orange Book
A215234
AO
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "22X328QOC4",
    "rxcui": "282357",
    "inchikey": "VWUXBMIQPBEWFH-WCCTWKNTSA-N",
    "display_name": "FULVESTRANT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "d5ae9e07-73b0-4063-a9e4-0ffc5614c2b8": {
      "match": "brand_token",
      "title": "FULVESTRANT INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]",
      "spl_version": "1",
      "published_date": "2026-04-15"
    }
  },
  "productid": "70710-1688_b2f2e6fc-229a-46a6-ad64-02e665f8e942",
  "productndc": "70710-1688",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215234",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AO",
        "strength": "250MG/5ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 29, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FULVESTRANT",
  "proprietary_name": "FULVESTRANT",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215234",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fulvestrant",
  "start_marketing_date": "20211214",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code L02BA03.

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