🇺🇸
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
- ndc1167457926501 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.
- FIAbelcetTeva Pharma B.V.
- PLAbelcetTeva Pharmaceuticals Polska Sp. z o.o.
- GBAbelcet 50mg/10ml suspension for injection vialsCephalon Ltd
- 🇪🇸ABELCET COMPLEJO LIPIDICO 5 mg/ml CONCENTRADO PARA DISPERSION PARA PERFUSIONTeva Pharma S.L.U.
- FIAbelcet Lipid ComplexParanova Oy
- CZABELCET LIPID COMPLEXTeva Pharmaceuticals CR, s.r.o., Praha
- CZABELCET LIPID COMPLEXTeva Pharmaceuticals CR, s.r.o., Praha
- BEAbelcet Lipid Complex 5 mg/mlTeva Pharma Belgium
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