Neomycin and Polymyxin B Sulfates and Hydrocortisone
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP (Sterile)
Approved
Approval ID
5af59404-0604-4d1b-865f-b72425622760
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0708
Application NumberANDA064053
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateApril 27, 2011
FDA Product Classification
INGREDIENTS (9)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 mL
Code: 057Y626693
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIB
HYDROCORTISONEActive
Quantity: 10 mg in 1 mL
Code: WI4X0X7BPJ
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POTASSIUM METABISULFITEInactive
Code: 65OE787Q7W
Classification: IACT
CUPRIC SULFATEInactive
Code: LRX7AJ16DT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 1/31/2011
Rx only
FOR USE IN THE EARS ONLY
NOT FOR USE IN THE EYES