Betadine
Betadine® 5%Sterile OphthalmicPrep Solution(povidone-iodine ophthalmic solution)(0.5% available iodine)
Approved
Approval ID
72287bb4-3f70-4e12-aaf3-cfff48e044f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
povidone-iodine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-006
Application NumberNDA018634
Product Classification
M
Marketing Category
C73594
G
Generic Name
povidone-iodine
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 17, 2009
FDA Product Classification
INGREDIENTS (7)
POVIDONE-IODINEActive
Quantity: 5 mg in 1 mL
Code: 85H0HZU99M
Classification: ACTIM
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
NONOXYNOL-9Inactive
Code: 48Q180SH9T
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT