Ranitidine

Product NDC
65162-254
11-digit product format
651620254
Labeler code
65162
Product ID
65162-254_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
300 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-254-03EA - Each65162-254eb2bd4da-1dee-43b7-be10-72b77df456ce12017-08-11
65162-254-10EA - Each65162-254c6355d1b-35a8-4d2f-84d6-0255955a905012017-08-11
65162-254-25EA - Each65162-25480c33bc4-bad8-42f2-bb1e-02cd090f8fff12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-254RANITIDINE TABLET [AMNEAL PHARMACEUTICALS LLC]7Legacy NDC20241031_9f416ce0-012f-4194-9382-74ac71e4b2a9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-254-036516202540330 TABLET in 1 BOTTLE (65162-254-03) 30 tablet2009-12-160000-00-00NoNoCurrent
65162-254-1065162025410100 TABLET in 1 BOTTLE (65162-254-10) 100 tablet2009-12-160000-00-00NoNoCurrent
65162-254-11651620254111000 TABLET in 1 BOTTLE (65162-254-11) 1000 tablet2009-12-160000-00-00NoNoCurrent
65162-254-2565162025425250 TABLET in 1 BOTTLE (65162-254-25) 250 tablet2009-12-160000-00-00NoNoCurrent