NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP (Sterile)
Approved
Approval ID
af2504c0-239b-460a-b765-8e0dfa4e629d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-170
Application NumberANDA064064
Product Classification
M
Marketing Category
C73584
G
Generic Name
NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 9, 2010
FDA Product Classification
INGREDIENTS (5)
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 1000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIB
BACITRACIN ZINCActive
Quantity: 400 [USP'U] in 1 g
Code: 89Y4M234ES
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT