PEMETREXED DIPOTASSIUM

In shortageOrange BookUNIISPLATC L01BA04

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

Identification

ManufacturerAvyxa Pharma, LLC

CountryUS (United States)

ATC codeL01BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8383111101
1 VIAL in 1 CARTON (83831-111-01) / 4 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

04Q9AIZ7NO

PEMETREXED

RxCUI 68446

Orange Book

N210661

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Pemetrexed Ditromethamine Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "04Q9AIZ7NO",
    "rxcui": "68446",
    "inchikey": "WBXPDJSOTKVWSJ-ZDUSSCGKSA-N",
    "display_name": "PEMETREXED",
    "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": "83831-111_0c1baa15-83bb-45a0-a3ab-855a4fee9129",
  "productndc": "83831-111",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "210661",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jun 28, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jun 28, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEMETREXED",
  "shortage_reason": "Pemetrexed Ditromethamine Injection",
  "shortage_status": "current",
  "proprietary_name": "PEMETREXED DIPOTASSIUM",
  "active_ingred_unit": "mg/4mL",
  "application_number": "NDA210661",
  "marketing_category": "NDA",
  "nonproprietary_name": "pemetrexed dipotassium",
  "start_marketing_date": "20250101",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code L01BA04.

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