Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC
49999-254
11-digit product format
499990254
Labeler code
49999
Product ID
49999-254_6fb3ace1-099f-44a2-9959-655d3b006169
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA064053
Marketing category
ANDA
Marketing start
1995-12-29
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
Active strength
4 mg/mL; [USP'U]/mL; mg/mL
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-254-10ML - Milliliter49999-2543315c212-e0ef-457e-ab25-a8ea5c26963a12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49999-254-10499990254101 BOTTLE, DROPPER in 1 CARTON (49999-254-10) > 10 mL in 1 BOTTLE, DROPPER1995-12-290000-00-00NoNoCurrent