Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC
68788-7684
11-digit product format
687887684
Labeler code
68788
Product ID
68788-7684_7b2af16d-a485-4cd8-b1dc-2f32f6bcb883
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and hydrocortisone
Dosage form
SUSPENSION
Route
AURICULAR (OTIC)
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA062488
Marketing category
ANDA
Marketing start
2020-03-24
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7684-1ML - Milliliter68788-76849d0da823-084f-4f22-acfc-c639e1bdf0f412020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7684-16878876840110 mL in 1 BOTTLE, PLASTIC (68788-7684-1) 10 ml2020-03-240000-00-00NoNoCurrent