amphotericin b

Generic: amphotericin b

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amphotericin b
Generic Name amphotericin b
Labeler xgen pharmaceuticals djb, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amphotericin b 50 mg/10mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-1055
Product ID 39822-1055_ff6c6de5-ba12-4176-817f-359761f6e4bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA063206
Listing Expiration 2026-12-31
Marketing Start 1992-04-29

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 398221055
Hyphenated Format 39822-1055

Supplemental Identifiers

RxCUI
239240
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 ANDA063206 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 10 mL in 1 VIAL (39822-1055-5)
source: ndc

Packages (1)

39822-1055-5 10 mL in 1 VIAL (39822-1055-5)

Ingredients (1)

amphotericin b (50 mg/10mL)

Linked Drug Pages (1)

Amphotericin B ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ff6c6de5-ba12-4176-817f-359761f6e4bf", "openfda": {"nui": ["N0000175510", "N0000175498", "M0017172"], "unii": ["7XU7A7DROE"], "rxcui": ["239240"], "spl_set_id": ["a0a54943-9ce4-4f3e-b681-a1a9144c16ce"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Lipid-based Polyene Antifungal [EPC]", "Polyene Antifungal [EPC]"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL (39822-1055-5)", "package_ndc": "39822-1055-5", "marketing_start_date": "19920429"}], "brand_name": "Amphotericin B", "product_id": "39822-1055_ff6c6de5-ba12-4176-817f-359761f6e4bf", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipid-based Polyene Antifungal [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "39822-1055", "generic_name": "Amphotericin B", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amphotericin B", "active_ingredients": [{"name": "AMPHOTERICIN B", "strength": "50 mg/10mL"}], "application_number": "ANDA063206", "marketing_category": "ANDA", "marketing_start_date": "19920429", "listing_expiration_date": "20261231"}