Back to search
🇺🇸

United States · US · US:67457-926_a96a734f-d1c4-4d42-93c2-7c336da7f7b9

Amphotericin B liposome

In shortageOrange BookUNIISPLATC J02AA01

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

Identification

ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeJ02AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6745792650
    1 VIAL, SINGLE-DOSE in 1 CARTON (67457-926-50) / 12.5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
7XU7A7DROE
AMPHOTERICIN B
RxCUI 732
Orange Book
A212967
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": {
    "593cffa0-c305-48b6-8ec7-331e0ff91d2b": {
      "match": "brand_token",
      "title": "AMPHOTERICIN B INJECTABLE, LIPOSOMAL [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "4",
      "published_date": "2026-04-22"
    }
  },
  "productid": "67457-926_a96a734f-d1c4-4d42-93c2-7c336da7f7b9",
  "productndc": "67457-926",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "212967",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 30, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMPHOTERICIN B",
  "shortage_reason": "Amphotericin B Injection",
  "shortage_status": "current",
  "proprietary_name": "Amphotericin B liposome",
  "active_ingred_unit": "mg/12.5mL",
  "application_number": "ANDA212967",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amphotericin B liposome",
  "start_marketing_date": "20250806",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code J02AA01.

Access this data programmatically

Query Amphotericin B liposome and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.