Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
68788-9373
11-digit product format
687889373
Labeler code
68788
Product ID
68788-9373_47fe6ec2-67f9-4b79-8508-f1c175a77bc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin, Polymyxin B Sulfates, Dexamethasone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA062938
Marketing category
ANDA
Marketing start
2014-09-02
Marketing end
0000-00-00
Substance
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
1 mg/g; mg/g; [USP'U]/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9373-3687889373031 TUBE in 1 CARTON (68788-9373-3) > 3.5 g in 1 TUBE1 tube2014-09-020000-00-00NoNoCurrent