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United States · US · US:0781-3520_764ab64b-c642-4314-83a9-efee79fe83a3

Pemetrexed

In shortageOrange BookUNIISPLATC L01BA04

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

Identification

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

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
2PKU919BA9
PEMETREXED DISODIUM
RxCUI 282443
Orange Book
N214657
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pemetrexed Ditromethamine Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "2PKU919BA9",
    "rxcui": "282443",
    "inchikey": "NYDXNILOWQXUOF-GXKRWWSZSA-L",
    "display_name": "PEMETREXED DISODIUM",
    "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": "0781-3520_764ab64b-c642-4314-83a9-efee79fe83a3",
  "productndc": "0781-3520",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214657",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE/4ML (EQ 25MG BASE/ML)",
        "product_no": "001",
        "approval_date": "May 26, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG BASE/20ML (EQ 25MG BASE/ML)",
        "product_no": "002",
        "approval_date": "May 26, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/40ML (EQ 25MG BASE/ML)",
        "product_no": "003",
        "approval_date": "May 26, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEMETREXED DISODIUM",
  "shortage_reason": "Pemetrexed Ditromethamine Injection",
  "shortage_status": "current",
  "proprietary_name": "Pemetrexed",
  "active_ingred_unit": "mg/40mL",
  "application_number": "NDA214657",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pemetrexed disodium",
  "start_marketing_date": "20220608",
  "active_numerator_strength": "1000"
}

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