RANITIDINE

Product NDC
58602-733
11-digit product format
586020733
Labeler code
58602
Product ID
58602-733_8f1b503c-2663-45a1-b9f6-c951509f6958
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA207579
Marketing category
ANDA
Marketing start
2017-11-13
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
75 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-733-03586020733031 BLISTER PACK in 1 CARTON (58602-733-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2017-11-130000-00-00NoNoCurrent
58602-733-09586020733091 BOTTLE in 1 CARTON (58602-733-09) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-11-130000-00-00NoNoCurrent
58602-733-15586020733151 BOTTLE in 1 CARTON (58602-733-15) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-11-130000-00-00NoNoCurrent
58602-733-18586020733181 BOTTLE in 1 CARTON (58602-733-18) > 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-11-130000-00-00NoNoCurrent
58602-733-22586020733221 BOTTLE in 1 CARTON (58602-733-22) > 105 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-11-130000-00-00NoNoCurrent
58602-733-23586020733231 BOTTLE in 1 CARTON (58602-733-23) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-11-130000-00-00NoNoCurrent
58602-733-30586020733301 BOTTLE in 1 CARTON (58602-733-30) > 160 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-11-130000-00-00NoNoCurrent
58602-733-40586020733401 BOTTLE in 1 CARTON (58602-733-40) > 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-11-130000-00-00NoNoCurrent