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United States · US · US:71288-148_b369ac27-0118-4e53-be05-c9ba2dbf6875

Pemetrexed

In shortageOrange BookUNIISPLATC L01BA04

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

Identification

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

Packs · 1

  • ndc11
    7128814851
    1 VIAL, SINGLE-DOSE in 1 CARTON (71288-148-51) / 40 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
9T47E4OM16
PEMETREXED DISODIUM HEPTAHYDRATE
RxCUI 1666923
Orange Book
A215479
APAPAPAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pemetrexed Disodium Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "9T47E4OM16",
    "rxcui": "1666923",
    "inchikey": "QJVSMHJWAOSBMD-MYXYZBIASA-L",
    "display_name": "PEMETREXED DISODIUM HEPTAHYDRATE",
    "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": "71288-148_b369ac27-0118-4e53-be05-c9ba2dbf6875",
  "productndc": "71288-148",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "215479",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 13, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Dec 13, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 750MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Dec 13, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "Dec 13, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEMETREXED DISODIUM HEPTAHYDRATE",
  "shortage_reason": "Pemetrexed Disodium Injection",
  "shortage_status": "current",
  "proprietary_name": "Pemetrexed",
  "active_ingred_unit": "g/40mL",
  "application_number": "ANDA215479",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pemetrexed disodium",
  "start_marketing_date": "20221213",
  "active_numerator_strength": "1"
}

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