ambisome

Generic: amphotericin b

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ambisome
Generic Name amphotericin b
Labeler astellas pharma us, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amphotericin b 50 mg/12.5mL

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-3051
Product ID 0469-3051_1369d969-91c2-42dc-b8c5-27e8703a2b68
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050740
Listing Expiration 2026-12-31
Marketing Start 1997-08-11

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 04693051
Hyphenated Format 0469-3051

Supplemental Identifiers

RxCUI
967385 967388
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 ambisome (source: ndc)
Generic Name amphotericin b (source: ndc)
Application Number NDA050740 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/12.5mL
source: ndc
Packaging
  • 12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30)
source: ndc

Packages (1)

0469-3051-30 12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30)

Ingredients (1)

amphotericin b (50 mg/12.5mL)

Linked Drug Pages (1)

AmBisome ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1369d969-91c2-42dc-b8c5-27e8703a2b68", "openfda": {"nui": ["N0000175510", "N0000175498", "M0017172"], "unii": ["7XU7A7DROE"], "rxcui": ["967385", "967388"], "spl_set_id": ["f7be6506-4d20-401e-a0ff-02ad7c33158a"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Lipid-based Polyene Antifungal [EPC]", "Polyene Antifungal [EPC]"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30)", "package_ndc": "0469-3051-30", "marketing_start_date": "19970811"}], "brand_name": "AmBisome", "product_id": "0469-3051_1369d969-91c2-42dc-b8c5-27e8703a2b68", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipid-based Polyene Antifungal [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "0469-3051", "generic_name": "amphotericin B", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AmBisome", "active_ingredients": [{"name": "AMPHOTERICIN B", "strength": "50 mg/12.5mL"}], "application_number": "NDA050740", "marketing_category": "NDA", "marketing_start_date": "19970811", "listing_expiration_date": "20261231"}