Amphotericin B
Amphotericin B for Injection USP Rx Only
Approved
Approval ID
a0a54943-9ce4-4f3e-b681-a1a9144c16ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2022
Manufacturers
FDA
XGen Pharmaceuticals DJB, Inc.
DUNS: 117380305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amphotericin B
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39822-1055
Application NumberANDA063206
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amphotericin B
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (7)
NITROGENInactive
Code: N762921K75
Classification: IACT
AMPHOTERICIN BActive
Quantity: 50 mg in 10 mL
Code: 7XU7A7DROE
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 1.02 mg in 10 mL
Code: 593YOG76RN
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DEOXYCHOLIC ACIDInactive
Quantity: 38.75 mg in 10 mL
Code: 005990WHZZ
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Quantity: 18.85 mg in 10 mL
Code: GR686LBA74
Classification: IACT