FDA.reportPublic FDA data

Ranitidine

Product NDC
0440-8300
11-digit product format
004408300
Labeler code
0440
Product ID
0440-8300_72a1666b-a50d-4ea5-9492-1b28ecc4bf70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
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
E
Listing certified through
2018-12-31
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
0440-8300-602020-01-31C16284748780-19d75b9d0-b59c-f424-e053-dadaa90a57ceRanitidine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-8300-60Ranitidine60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-8300-60EA - Each0440-83000aca0c05-e201-4f03-8887-919154a39ee412015-06-09

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-8300RANITIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20131204_f19c60c8-e1f3-4d1f-80d3-833e67f33339.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNf19c60c8-e1f3-4d1f-80d3-833e67f333391
198191ranitidine 150 MG Oral TabletSCDf19c60c8-e1f3-4d1f-80d3-833e67f333391
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYf19c60c8-e1f3-4d1f-80d3-833e67f333391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-8300-600044083006060 in 1 BOTTLE, PLASTICHistorical