Ranitidine

Product NDC
43353-445
11-digit product format
433530445
Labeler code
43353
Product ID
43353-445_515aa4a3-308a-4d12-915e-5684210081eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-12-16
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-445-60EA - Each43353-44558edcb99-536c-4dcb-b04e-2225aae113a712017-12-14
43353-445-80EA - Each43353-445568f181f-e789-4a7b-9eb7-cf37cd9a0d4712017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-445RANITIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20171127_f4b81ce4-7fad-4a2b-a9a7-bc646d57543a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-445-604335304456090 TABLET in 1 BOTTLE (43353-445-60) 90 tablet2010-06-290000-00-00NoNoCurrent
43353-445-8043353044580180 TABLET in 1 BOTTLE (43353-445-80) 180 tablet2009-12-230000-00-00NoNoCurrent