amphotericin b liposome (67457-926)

Drug Facts

Product Profile

Brand Name amphotericin b liposome

Generic Name amphotericin b liposome

Labeler mylan institutional llc

Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

Routes

INTRAVENOUS

Active Ingredients

amphotericin b 50 mg/12.5mL

Manufacturer

Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-926

Product ID 67457-926_a96a734f-d1c4-4d42-93c2-7c336da7f7b9

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212967

Listing Expiration 2026-12-31

Marketing Start 2025-08-06

Pharmacologic Class

Established (EPC)

lipid-based polyene antifungal [epc] polyene antifungal [epc]

Chemical Structure

polyenes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457926

Hyphenated Format 67457-926

Supplemental Identifiers

RxCUI

967385

UNII

7XU7A7DROE

NUI

N0000175510 N0000175498 M0017172

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amphotericin b liposome (source: ndc)

Generic Name amphotericin b liposome (source: ndc)

Application Number ANDA212967 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

50 mg/12.5mL

source: ndc

Packaging

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-926-50) / 12.5 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (1)

67457-926-50 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-926-50) / 12.5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

amphotericin b (50 mg/12.5mL)

Linked Drug Pages (1)

Amphotericin B liposome ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "a96a734f-d1c4-4d42-93c2-7c336da7f7b9", "openfda": {"nui": ["N0000175510", "N0000175498", "M0017172"], "unii": ["7XU7A7DROE"], "rxcui": ["967385"], "spl_set_id": ["a96a734f-d1c4-4d42-93c2-7c336da7f7b9"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Lipid-based Polyene Antifungal [EPC]", "Polyene Antifungal [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-926-50)  / 12.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67457-926-50", "marketing_start_date": "20250806"}], "brand_name": "Amphotericin B liposome", "product_id": "67457-926_a96a734f-d1c4-4d42-93c2-7c336da7f7b9", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Lipid-based Polyene Antifungal [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "67457-926", "generic_name": "Amphotericin B liposome", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amphotericin B liposome", "active_ingredients": [{"name": "AMPHOTERICIN B", "strength": "50 mg/12.5mL"}], "application_number": "ANDA212967", "marketing_category": "ANDA", "marketing_start_date": "20250806", "listing_expiration_date": "20261231"}