PEMRYDI RTU

In shortageOrange BookUNIISPLATC L01BA04

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeL01BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7012124531
1 VIAL in 1 CARTON (70121-2453-1) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

F4GSH45R4C

PEMETREXED DISODIUM HEMIPENTAHYDRATE

RxCUI 2056898

Orange Book

N215179

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Pemetrexed Ditromethamine 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": {
    "0f006b06-ab85-423d-ba0c-dfc3fc25844e": {
      "match": "brand_token",
      "title": "PEMRYDI RTU (PEMETREXED DISODIUM) INJECTION [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "8",
      "published_date": "2025-08-04"
    }
  },
  "productid": "70121-2453_b6a00be1-95d1-4b91-93bf-4430a57eeff6",
  "productndc": "70121-2453",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215179",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG/10ML BASE (10MG/ML)",
        "product_no": "001",
        "approval_date": "May 22, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG/50ML BASE (10MG/ML)",
        "product_no": "002",
        "approval_date": "May 22, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM/100ML BASE (10MG/ML)",
        "product_no": "003",
        "approval_date": "May 22, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEMETREXED DISODIUM HEMIPENTAHYDRATE",
  "shortage_reason": "Pemetrexed Ditromethamine Injection",
  "shortage_status": "current",
  "proprietary_name": "PEMRYDI RTU",
  "active_ingred_unit": "mg/10mL",
  "application_number": "NDA215179",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pemetrexed disodium",
  "start_marketing_date": "20230606",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code L01BA04.

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