FOSAPREPITANT DIMEGLUMINE

In shortageOrange BookUNIISPL

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143938401
1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9384-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

D35FM8T64X

FOSAPREPITANT DIMEGLUMINE

RxCUI 754763

Orange Book

A213106

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": {
    "679c195a-cf59-4ca5-aa05-fa35d08ddb5c": {
      "match": "brand_token",
      "title": "FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "100",
      "published_date": "2026-05-11"
    }
  },
  "productid": "0143-9384_ca5262d4-3072-4a53-83e0-435a4d3ca608",
  "productndc": "0143-9384",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "213106",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 150MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Sep 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOSAPREPITANT DIMEGLUMINE",
  "shortage_reason": "Fosaprepitant Dimeglumine Injection",
  "shortage_status": "current",
  "proprietary_name": "FOSAPREPITANT DIMEGLUMINE",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA213106",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FOSAPREPITANT DIMEGLUMINE",
  "start_marketing_date": "20200908",
  "active_numerator_strength": "150"
}

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