NDC 0469-3051

AmBisome

Amphotericin B

AmBisome is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Amphotericin B.

• Product ID: 0469-3051_5f3f2915-440e-4faa-9e4d-71efae2f50e8
• NDC: 0469-3051
• Product Type: Human Prescription Drug
• Proprietary Name: AmBisome
• Generic Name: Amphotericin B
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1997-08-11
• Marketing Category: NDA / NDA
• Application Number: NDA050740
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: AMPHOTERICIN B
• Active Ingredient Strength: 50 mg/12.5mL
• Pharm Classes: Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0469-3051-30

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

• Marketing Start Date: 1997-08-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0469-3051-30 [00469305130]

AmBisome INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA050740
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-08-11

Drug Details

Active Ingredients

Ingredient	Strength
AMPHOTERICIN B	50 mg/12.5mL

OpenFDA Data

• SPL SET ID: f7be6506-4d20-401e-a0ff-02ad7c33158a
• Manufacturer:
  • Astellas Pharma US, Inc.
• UNII:
  • 7XU7A7DROE
• RxNorm Concept Unique ID - RxCUI:
  • 967385
  • 967388
• UPC Code:
  • 0304693051302

Pharmacological Class

• Lipid-based Polyene Antifungal [EPC]
• Polyene Antifungal [EPC]
• Polyenes [CS]

NDC Crossover Matching brand name "AmBisome" or generic name "Amphotericin B"

NDC	Brand Name	Generic Name
0469-3051	AmBisome	amphotericin B
39822-1055	Amphotericin B	Amphotericin B
55150-365	Amphotericin B	Amphotericin B
62756-233	Amphotericin B	Amphotericin B