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United States · US · US:43598-387_ad279b3e-152b-998b-a0d8-f96ecff31439

Pemetrexed disodium

In shortageOrange BookUNIISPLATC L01BA04

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

Identification

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

Packs · 1

  • ndc11
    4359838711
    1 VIAL, SINGLE-DOSE in 1 CARTON (43598-387-11) / 20 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
2PKU919BA9
PEMETREXED DISODIUM
RxCUI 282443
Orange Book
A202596
APAPAP
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": "43598-387_ad279b3e-152b-998b-a0d8-f96ecff31439",
  "productndc": "43598-387",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "202596",
    "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": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "003",
        "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 disodium",
  "active_ingred_unit": "mg/20mL",
  "application_number": "ANDA202596",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pemetrexed disodium",
  "start_marketing_date": "20220525",
  "active_numerator_strength": "500"
}

Related drugs

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