MAXITROL

Product NDC
0065-0631
11-digit product format
000650631
Labeler code
0065
Product ID
0065-0631_7cafb7c6-1bf0-42d8-aa07-bc544149b50d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA050065
Marketing category
NDA
Marketing start
1972-01-17
Marketing end
2024-05-31
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength
4 mg/g; [USP'U]/g; mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0631-36GM - Gram0065-06313382257f-8815-4432-a4ab-510bfda2d69d12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-0631-36000650631363.5 g in 1 TUBE (0065-0631-36) 3.5 g1972-01-172024-05-31NoNoCurrent