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United States · US · US:67184-0504_0dc735ab-c4c9-4e19-bb80-8a439be7208c

Pemetrexed

In shortageOrange BookUNIISPLATC L01BA04

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

Identification

ManufacturerQilu Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeL01BA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6718405041
    1 VIAL in 1 CARTON (67184-0504-1) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
F4GSH45R4C
PEMETREXED DISODIUM HEMIPENTAHYDRATE
RxCUI 2056898
Orange Book
A204890
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pemetrexed Disodium Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "F4GSH45R4C",
    "rxcui": "2056898",
    "inchikey": "ZCTCZKWJFTYNMZ-WKUCUCPSSA-J",
    "display_name": "PEMETREXED DISODIUM HEMIPENTAHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "bd0ada98-3237-4465-8ba2-3a12c33116fb": {
      "match": "brand_token",
      "title": "PEMETREXED INJECTION, POWDER, FOR SOLUTION [SOLCO HEALTHCARE US, LLC]",
      "spl_version": "2",
      "published_date": "2026-02-06"
    }
  },
  "productid": "67184-0504_0dc735ab-c4c9-4e19-bb80-8a439be7208c",
  "productndc": "67184-0504",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "204890",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 25, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "May 25, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEMETREXED DISODIUM HEMIPENTAHYDRATE",
  "shortage_reason": "Pemetrexed Disodium Injection",
  "shortage_status": "current",
  "proprietary_name": "Pemetrexed",
  "active_ingred_unit": "mg/20mL",
  "application_number": "ANDA204890",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pemetrexed disodium",
  "start_marketing_date": "20220525",
  "active_numerator_strength": "500"
}

Related drugs

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