🇺🇸
United States · US · US:0469-3051_1369d969-91c2-42dc-b8c5-27e8703a2b68
AmBisome
In shortageOrange BookUNIISPLATC J02AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstellas Pharma US, Inc.
CountryUS (United States)
ATC codeJ02AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11046930513012.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30)
Annotations
UNII (FDA Substance ID)
7XU7A7DROE
AMPHOTERICIN B
RxCUI 732
Orange Book
N050740
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": {
"f7be6506-4d20-401e-a0ff-02ad7c33158a": {
"match": "brand_token",
"title": "AMBISOME (AMPHOTERICIN B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.]",
"spl_version": "13",
"published_date": "2025-06-18"
}
},
"productid": "0469-3051_1369d969-91c2-42dc-b8c5-27e8703a2b68",
"productndc": "0469-3051",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "050740",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "50MG/VIAL",
"product_no": "001",
"approval_date": "Aug 11, 1997"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMPHOTERICIN B",
"shortage_reason": "Amphotericin B Injection",
"shortage_status": "current",
"proprietary_name": "AmBisome",
"active_ingred_unit": "mg/12.5mL",
"application_number": "NDA050740",
"marketing_category": "NDA",
"nonproprietary_name": "amphotericin B",
"start_marketing_date": "19970811",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code J02AA01.
- PLAbelcetTeva Pharmaceuticals Polska Sp. z o.o.
- FIAbelcetTeva Pharma B.V.
- 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
Access this data programmatically
Query AmBisome 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.