amphotericin b

Generic: amphotericin b

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amphotericin b
Generic Name amphotericin b
Labeler eugia us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amphotericin b 50 mg/12.5mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-365
Product ID 55150-365_9f45e5d9-6acd-491e-a80c-f07ecc6ac109
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214010
Listing Expiration 2026-12-31
Marketing Start 2022-11-17

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 55150365
Hyphenated Format 55150-365

Supplemental Identifiers

RxCUI
967385
UPC
0355150365012
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 (source: ndc)
Generic Name amphotericin b (source: ndc)
Application Number ANDA214010 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/12.5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-365-01) / 12.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-365-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-365-01) / 12.5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

amphotericin b (50 mg/12.5mL)

Linked Drug Pages (1)

Amphotericin B ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9f45e5d9-6acd-491e-a80c-f07ecc6ac109", "openfda": {"nui": ["N0000175510", "N0000175498", "M0017172"], "upc": ["0355150365012"], "unii": ["7XU7A7DROE"], "rxcui": ["967385"], "spl_set_id": ["6f24975c-5191-4fc2-a8da-e57358f8e154"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Lipid-based Polyene Antifungal [EPC]", "Polyene Antifungal [EPC]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-365-01)  / 12.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-365-01", "marketing_start_date": "20221117"}], "brand_name": "Amphotericin B", "product_id": "55150-365_9f45e5d9-6acd-491e-a80c-f07ecc6ac109", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipid-based Polyene Antifungal [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "55150-365", "generic_name": "Amphotericin B", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amphotericin B", "active_ingredients": [{"name": "AMPHOTERICIN B", "strength": "50 mg/12.5mL"}], "application_number": "ANDA214010", "marketing_category": "ANDA", "marketing_start_date": "20221117", "listing_expiration_date": "20261231"}