Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone

Product NDC

13985-745

11-digit product format

139850745

Labeler code

13985

Product ID

13985-745_724ddfb3-be4c-4da4-bd96-4193981c6cde

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone

Dosage form

OINTMENT

Route

OPHTHALMIC

Labeler

MWI

Application

ANDA064068

Marketing category

ANDA

Marketing start

1995-10-30

Marketing end

0000-00-00

Substance

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE

Active strength

4 mg/g; [USP'U]/g; [USP'U]/g; mg/g

Pharmacologic classes

Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record