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United States · US · US:0469-3051_1369d969-91c2-42dc-b8c5-27e8703a2b68

AmBisome

In shortageOrange BookUNIISPLATC J02AA01

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

Identification

ManufacturerAstellas Pharma US, Inc.
CountryUS (United States)
ATC codeJ02AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0469305130
    12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30)

Annotations

UNII (FDA Substance ID)
7XU7A7DROE
AMPHOTERICIN B
RxCUI 732
Orange Book
N050740
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amphotericin B Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "7XU7A7DROE",
    "rxcui": "732",
    "inchikey": "APKFDSVGJQXUKY-INPOYWNPSA-N",
    "display_name": "AMPHOTERICIN B",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f7be6506-4d20-401e-a0ff-02ad7c33158a": {
      "match": "brand_token",
      "title": "AMBISOME (AMPHOTERICIN B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.]",
      "spl_version": "13",
      "published_date": "2025-06-18"
    }
  },
  "productid": "0469-3051_1369d969-91c2-42dc-b8c5-27e8703a2b68",
  "productndc": "0469-3051",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "050740",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Aug 11, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMPHOTERICIN B",
  "shortage_reason": "Amphotericin B Injection",
  "shortage_status": "current",
  "proprietary_name": "AmBisome",
  "active_ingred_unit": "mg/12.5mL",
  "application_number": "NDA050740",
  "marketing_category": "NDA",
  "nonproprietary_name": "amphotericin B",
  "start_marketing_date": "19970811",
  "active_numerator_strength": "50"
}

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