Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment
Approved
Approval ID
aa7b8a3f-06dd-4190-96a5-f86195bd2197
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2021
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Neomycin and Polymyxin B Sulfates and Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-330
Application NumberNDA050065
Product Classification
M
Marketing Category
C73605
G
Generic Name
Neomycin and Polymyxin B Sulfates and Dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 1, 2021
FDA Product Classification
INGREDIENTS (7)
DEXAMETHASONEActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 [iU] in 1 g
Code: 19371312D4
Classification: ACTIM
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT