Ciprofloxacin and Dexamethasone

Product NDC
63629-8797
11-digit product format
636298797
Labeler code
63629
Product ID
63629-8797_5e80f338-7937-4d9f-9e38-e6111b4ad4af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Bryant Ranch Prepack
Application
NDA021537
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-08-10
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active strength
3 mg/mL; mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Quinolone Antimicrobial [EPC], Quinolones [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
63629-8797-1ML - Milliliter63629-87977ba6b3a4-0c3e-499f-9f60-f2997c6d42f612021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8797CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION/ DROPS [BRYANT RANCH PREPACK]102Legacy NDC20240113_873dadbe-1e7b-4790-bcc3-e60e5339203f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8797-1636298797011 BOTTLE, DROPPER in 1 CARTON (63629-8797-1) > 7.5 mL in 1 BOTTLE, DROPPER2021-09-100000-00-00NoNoCurrent