PEMETREXED

In shortageOrange BookUNIISPLATC L01BA04

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeL01BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0409104501
1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1045-01) / 4 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

2PKU919BA9

PEMETREXED DISODIUM

RxCUI 282443

Orange Book

N214218

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": "0409-1045_54cf7e63-ef81-4ced-b833-a73ad8980230",
  "productndc": "0409-1045",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "214218",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE/4ML (EQ 25MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jun 22, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG BASE/20ML (EQ 25MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Jun 22, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/40ML (EQ 25MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Jun 22, 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/4mL",
  "application_number": "NDA214218",
  "marketing_category": "NDA",
  "nonproprietary_name": "PEMETREXED",
  "start_marketing_date": "20220627",
  "active_numerator_strength": "100"
}

Related drugs

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