Bacitracin Zinc and Polymyxin B Sulfate
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP (Sterile) Rx only
Approved
Approval ID
51f6eac3-205e-4beb-8522-6ba2c593f350
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 24, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bacitracin Zinc and Polymyxin B Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-3274
Application NumberANDA064046
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bacitracin Zinc and Polymyxin B Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (4)
BACITRACIN ZINCActive
Quantity: 500 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIM
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT