Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

Product NDC
0404-7195
11-digit product format
004047195
Labeler code
0404
Product ID
0404-7195_c04237d3-3507-4001-8301-6de577cebe04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Henry Schein Inc.
Application
ANDA065213
Marketing category
ANDA
Marketing start
2015-05-13
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [USP'U]/g; mg/g; mg/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-7195-01004047195011 TUBE in 1 CARTON (0404-7195-01) > 3.5 g in 1 TUBE1 tube2015-05-130000-00-00NoNoCurrent