Neomycin, Polymyxin B Sulfates and Hydrocortisone
Approved
Approval ID
b5b31564-0bf8-43ef-8612-faa7093f1ab5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 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, Polymyxin B Sulfates and Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3250
Application NumberANDA062423
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin, Polymyxin B Sulfates and Hydrocortisone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 27, 2011
FDA Product Classification
INGREDIENTS (11)
THIMEROSALInactive
Code: 2225PI3MOV
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 mL
Code: 057Y626693
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIB
HYDROCORTISONEActive
Quantity: 100 mg in 1 mL
Code: WI4X0X7BPJ
Classification: ACTIB
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT