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United States · US · US:55150-365_9f45e5d9-6acd-491e-a80c-f07ecc6ac109

Amphotericin B

In shortageOrange BookUNIISPLATC J02AA01

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

Identification

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

Packs · 1

  • ndc11
    5515036501
    1 VIAL, SINGLE-DOSE in 1 CARTON (55150-365-01) / 12.5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
7XU7A7DROE
AMPHOTERICIN B
RxCUI 732
Orange Book
A214010
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": "55150-365_9f45e5d9-6acd-491e-a80c-f07ecc6ac109",
  "productndc": "55150-365",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214010",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Nov 17, 2022"
      }
    ],
    "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",
  "active_ingred_unit": "mg/12.5mL",
  "application_number": "ANDA214010",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amphotericin B",
  "start_marketing_date": "20221117",
  "active_numerator_strength": "50"
}

Related drugs

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