FOCINVEZ

In shortageOrange BookUNIISPL

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7012126311
1 VIAL, SINGLE-DOSE in 1 CARTON (70121-2631-1) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

D35FM8T64X

FOSAPREPITANT DIMEGLUMINE

RxCUI 754763

Orange Book

N216686

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Fosaprepitant Dimeglumine Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "D35FM8T64X",
    "rxcui": "754763",
    "inchikey": "VRQHBYGYXDWZDL-OOZCZQCLSA-N",
    "display_name": "FOSAPREPITANT DIMEGLUMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "7afe33d8-5416-465a-b98b-f4eedc327a94": {
      "match": "brand_token",
      "title": "FOCINVEZ (FOSAPREPITANT DIMEGLUMINE) INJECTION [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "7",
      "published_date": "2026-04-20"
    }
  },
  "productid": "70121-2631_0ef109ec-d2f8-4c22-b20d-65db7f9c85a0",
  "productndc": "70121-2631",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216686",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE/50ML (EQ 3MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Aug 22, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOSAPREPITANT DIMEGLUMINE",
  "shortage_reason": "Fosaprepitant Dimeglumine Injection",
  "shortage_status": "current",
  "proprietary_name": "FOCINVEZ",
  "active_ingred_unit": "mg/50mL",
  "application_number": "NDA216686",
  "marketing_category": "NDA",
  "nonproprietary_name": "FOSAPREPITANT DIMEGLUMINE",
  "start_marketing_date": "20240601",
  "active_numerator_strength": "150"
}

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