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United States · US · US:62756-954_4acdbb90-5e56-4ab9-8a37-5dbeabc9c669

Amphotericin B

In shortageOrange BookUNIISPLATC J02AA01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeJ02AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6275695401
    1 VIAL, SINGLE-DOSE in 1 CARTON (62756-954-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE
  • ndc11
    6275695402
    10 CARTON in 1 CARTON (62756-954-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
7XU7A7DROE
AMPHOTERICIN B
RxCUI 732
Orange Book
A212514
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": "62756-954_4acdbb90-5e56-4ab9-8a37-5dbeabc9c669",
  "productndc": "62756-954",
  "dosage_form": "INJECTABLE, LIPOSOMAL",
  "orange_book": {
    "appl_no": "212514",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 14, 2021"
      }
    ],
    "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": "ANDA212514",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amphotericin B",
  "start_marketing_date": "20241201",
  "active_numerator_strength": "50"
}

Related drugs

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