CASPORYN HC

Product NDC
70199-011
11-digit product format
701990011
Labeler code
70199
Product ID
70199-011_26e37e84-0edd-410d-be1a-2bf71d2fe133
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin and polymyxin B sulfates and hydrocortisone otic
Dosage form
SUSPENSION
Route
AURICULAR (OTIC)
Labeler
Casper Pharma LLC
Application
NDA060613
Marketing category
NDA
Marketing start
2019-03-15
Marketing end
0000-00-00
Substance
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
10 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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70199-011CASPORYN HC (NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC) SUSPENSION [CASPER PHARMA LLC]6Legacy NDC20240606_14bb3363-1b52-4596-afcc-47457b064217.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70199-011-10701990011101 BOTTLE in 1 CARTON (70199-011-10) > 10 mL in 1 BOTTLE1 bottle2019-03-150000-00-00NoNoCurrent