Otiprio

Product NDC
69251-201
11-digit product format
692510201
Labeler code
69251
Product ID
69251-201_cea66fc0-da5a-403b-886e-b0eaacce39c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
SUSPENSION
Route
AURICULAR (OTIC); INTRATYMPANIC
Labeler
Otonomy, Inc.
Application
NDA207986
Marketing category
NDA
Marketing start
2016-02-11
Marketing end
2022-06-30
Substance
CIPROFLOXACIN
Active strength
60 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69251-201-012020-08-10C16284748780-19d75b9d1-193b-f424-e053-dadaa90a57ce8365e37a-0b35-497c-aab4-f25053378154
69251-201-012020-01-31C16284748780-19d75b9d1-193b-f424-e053-dadaa90a57ce8365e37a-0b35-497c-aab4-f25053378154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69251-201-01ML - Milliliter69251-2016eb40689-c1fb-4690-a124-3657245a046412016-03-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69251-201-01692510201011 VIAL, SINGLE-USE in 1 CARTON (69251-201-01) > 1 mL in 1 VIAL, SINGLE-USE2016-02-110000-00-00NoNoCurrent