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United States · US · US:23155-594_9de2927d-27ac-4890-ad71-a737dd4d3881

Amphotericin B

In shortageOrange BookUNIISPLATC J02AA01

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ02AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2315559431
    1 VIAL, SINGLE-DOSE in 1 CARTON (23155-594-31) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
7XU7A7DROE
AMPHOTERICIN B
RxCUI 732
Orange Book
A215354
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": "23155-594_9de2927d-27ac-4890-ad71-a737dd4d3881",
  "productndc": "23155-594",
  "dosage_form": "INJECTABLE, LIPOSOMAL",
  "orange_book": {
    "appl_no": "215354",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 2, 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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215354",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amphotericin B",
  "start_marketing_date": "20250620",
  "active_numerator_strength": "50"
}

Related drugs

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