Ranitidine

Product NDC
45865-416
11-digit product format
458650416
Labeler code
45865
Product ID
45865-416_9ab204d5-bc25-a818-e053-2995a90ad0da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
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
2020-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-416-602025-01-30C16284748780-12cef2736-5c01-d83d-e063-dadaa90ab31fRanitidine Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-416-60Ranitidine60 in 1 BOTTLETABLET602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [MEDSOURCE PHARMACEUTICALS]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-416RANITIDINE TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20191228_1d733324-93c6-201c-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN1d733324-93c6-201c-e054-00144ff88e882
198191ranitidine 150 MG Oral TabletSCD1d733324-93c6-201c-e054-00144ff88e882
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY1d733324-93c6-201c-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-416-604586504166060 TABLET in 1 BOTTLE (45865-416-60) 60 tablet2015-08-260000-00-00NoNoCurrent