Maxitrol

Product NDC
0078-0792
11-digit product format
000780792
Labeler code
0078
Product ID
0078-0792_ed267dc5-9db2-ee5f-e053-2a95a90af111
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA050023
Marketing category
NDA
Marketing start
1964-11-15
Marketing end
0000-00-00
Substance
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
1 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0792-05ML - Milliliter0078-07923f88d73a-2e2b-44ff-8a59-6d5de88393a912023-04-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0792-05000780792055 mL in 1 BOTTLE, PLASTIC (0078-0792-05) 5 ml2022-12-010000-00-00NoNoCurrent