CIPRODEX

Product NDC
71205-309
11-digit product format
712050309
Labeler code
71205
Product ID
71205-309_e39626a8-78f1-4c41-9384-df16361ad209
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Proficient Rx LP
Application
NDA021537
Marketing category
NDA
Marketing start
2003-08-04
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active strength
3 mg/mL; mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [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
71205-309-75ML - Milliliter71205-30988400032-a8bc-44ea-a5b0-f69d2d904b7512019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-309CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION/ DROPS [PROFICIENT RX LP]3Legacy NDC20200313_9b4466c2-bd57-49dd-8957-74f22f70e913.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-309-75712050309751 BOTTLE, DROPPER in 1 CARTON (71205-309-75) > 7.5 mL in 1 BOTTLE, DROPPER2019-08-010000-00-00NoNoCurrent