Neomycin and Polymyxin B Sulfates and Hydrocortisone
(Sterile)
Approved
Approval ID
6296e2ed-336b-b9af-e053-2991aa0aae0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2023
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 and Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-4229
Application NumberANDA064065
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateJune 16, 2023
FDA Product Classification
INGREDIENTS (9)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
HYDROCORTISONEActive
Quantity: 10 mg in 1 mL
Code: WI4X0X7BPJ
Classification: ACTIB
THIMEROSALInactive
Code: 2225PI3MOV
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 mL
Code: 057Y626693
Classification: ACTIM
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIM