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United States · US · US:63323-621_c7ff62a1-e697-4a7c-9907-59163f393528

Pemetrexed

In shortageOrange BookUNIISPLATC L01BA04

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01BA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332362100
    1 VIAL, SINGLE-USE in 1 CARTON (63323-621-00) / 30 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
2PKU919BA9
PEMETREXED DISODIUM
RxCUI 282443
Orange Book
A090384
APAPAPAP
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": "63323-621_c7ff62a1-e697-4a7c-9907-59163f393528",
  "productndc": "63323-621",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "090384",
    "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"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 750MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "May 25, 2022"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "May 25, 2022"
      }
    ],
    "appl_type": "A"
  },
  "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/30mL",
  "application_number": "ANDA090384",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PEMETREXED DISODIUM",
  "start_marketing_date": "20220525",
  "active_numerator_strength": "750"
}

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