Gatifloxacin

Product NDC
68180-435
11-digit product format
681800435
Labeler code
68180
Product ID
68180-435_0f7cdd76-0899-446d-945e-9b81a0dc6fd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gatifloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA202653
Marketing category
ANDA
Marketing start
2013-10-01
Marketing end
0000-00-00
Substance
GATIFLOXACIN
Active strength
5 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-435-01ML - Milliliter68180-435f3b64597-5e01-4817-9634-5ee0a2febbe512013-11-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-435-01681800435011 BOTTLE in 1 CARTON (68180-435-01) > 2.5 mL in 1 BOTTLE1 bottle2013-10-010000-00-00NoNoCurrent