PEMETREXED

In shortageOrange BookUNIISPLATC L01BA04

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

Identification

ManufacturerAccord Healthcare Inc.

CountryUS (United States)

ATC codeL01BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1672923011
1 VIAL in 1 CARTON (16729-230-11) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

F4GSH45R4C

PEMETREXED DISODIUM HEMIPENTAHYDRATE

RxCUI 2056898

Orange Book

A203485

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Pemetrexed Disodium Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "F4GSH45R4C",
    "rxcui": "2056898",
    "inchikey": "ZCTCZKWJFTYNMZ-WKUCUCPSSA-J",
    "display_name": "PEMETREXED DISODIUM HEMIPENTAHYDRATE",
    "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": "16729-230_1d874430-c6ce-cff2-e063-6394a90a4a49",
  "productndc": "16729-230",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "203485",
    "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 HEMIPENTAHYDRATE",
  "shortage_reason": "Pemetrexed Disodium Injection",
  "shortage_status": "current",
  "proprietary_name": "PEMETREXED",
  "active_ingred_unit": "mg/20mL",
  "application_number": "ANDA203485",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pemetrexed",
  "start_marketing_date": "20220525",
  "active_numerator_strength": "500"
}

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