Ranitidine

Product NDC
65162-253
11-digit product format
651620253
Labeler code
65162
Product ID
65162-253_e0ba270f-8460-4853-ae5d-6416a7b9cb79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-12-16
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f54af34-be54-4c3c-894f-78df6452d747Product name320190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850Product name520190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7bProduct name120180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228Product name120160720

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-253-06EA - Each65162-2533dacc511-c1a9-42e8-8b55-3ce8b98d1ac212017-08-11
65162-253-10EA - Each65162-253703bcee4-3cda-4bd8-970e-0bf0b144fdbe12017-08-11
65162-253-11EA - Each65162-25367b46867-f9c9-4c13-8c53-cb966b8359bb12017-08-11
65162-253-18EA - Each65162-25345caac8b-b367-4ed9-89e2-2834bae08e1112017-08-11
65162-253-50EA - Each65162-253ae4f88f8-d371-4988-99cb-5cdf1126666412017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-253RANITIDINE TABLET [AMNEAL PHARMACEUTICALS LLC]7Legacy NDC20241031_9f416ce0-012f-4194-9382-74ac71e4b2a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNda16ffa4-7fd1-40b8-a382-eb8421c992201
198191ranitidine 150 MG Oral TabletPSNdc729434-8340-40e3-9e5c-973c014601961
198191ranitidine 150 MG Oral TabletSCDda16ffa4-7fd1-40b8-a382-eb8421c992201
198191ranitidine 150 MG Oral TabletSCDdc729434-8340-40e3-9e5c-973c014601961
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYda16ffa4-7fd1-40b8-a382-eb8421c992201
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYdc729434-8340-40e3-9e5c-973c014601961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-253-066516202530660 TABLET in 1 BOTTLE (65162-253-06) 60 tablet2009-12-160000-00-00NoNoCurrent
65162-253-1065162025310100 TABLET in 1 BOTTLE (65162-253-10) 100 tablet2009-12-160000-00-00NoNoCurrent
65162-253-11651620253111000 TABLET in 1 BOTTLE (65162-253-11) 1000 tablet2009-12-160000-00-00NoNoCurrent
65162-253-1865162025318180 TABLET in 1 BOTTLE (65162-253-18) 180 tablet2009-12-160000-00-00NoNoCurrent
65162-253-5065162025350500 TABLET in 1 BOTTLE (65162-253-50) 500 tablet2009-12-160000-00-00NoNoCurrent