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United States · US · US:42367-531_efadeccf-c754-46aa-999e-4da07a4cd2ce

Pemfexy

In shortageOrange BookUNIISPLATC L01BA04

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

Identification

ManufacturerEagle Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01BA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4236753133
    1 VIAL in 1 CARTON (42367-531-33) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
236Y2F7D9J
PEMETREXED MONOHYDRATE
RxCUI 2590669
Orange Book
N209472
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pemetrexed Ditromethamine Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "236Y2F7D9J",
    "rxcui": "2590669",
    "inchikey": "NBNBOZLBWLNZHB-ZOWNYOTGSA-N",
    "display_name": "PEMETREXED MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "2308f4e8-21c8-49c1-a5b8-deb8610bac6a": {
      "match": "brand_token",
      "title": "PEMFEXY (PEMETREXED) INJECTION [EAGLE PHARMACEUTICALS, INC.]",
      "spl_version": "15",
      "published_date": "2026-02-25"
    }
  },
  "productid": "42367-531_efadeccf-c754-46aa-999e-4da07a4cd2ce",
  "productndc": "42367-531",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "209472",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "500MG/20ML (25MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 8, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEMETREXED MONOHYDRATE",
  "shortage_reason": "Pemetrexed Ditromethamine Injection",
  "shortage_status": "current",
  "proprietary_name": "Pemfexy",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA209472",
  "marketing_category": "NDA",
  "nonproprietary_name": "pemetrexed",
  "start_marketing_date": "20220201",
  "active_numerator_strength": "25"
}

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