FDA.reportPublic FDA data

Ranitidine

Product NDC
33358-316
11-digit product format
333580316
Labeler code
33358
Product ID
33358-316_dd0680b7-b318-445a-b849-04b1f75af80a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
RxChange Co.
Application
ANDA077824
Marketing category
ANDA
Marketing start
2014-11-25
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
2017-12-31
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
33358-316-302020-01-31C16284748780-19d75b9d0-931f-f424-e053-dadaa90a57ceRanitidine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-316-30Ranitidine30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-316-30EA - Each33358-316449b525e-4f80-4851-bbcd-6f4f408cc31212015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [RXCHANGE CO.]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [RXCHANGE CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-316RANITIDINE TABLET [RXCHANGE CO.]2Legacy NDC, 1 package rows20141201_5b9620b9-1660-4b35-b700-6b1347ed9ecb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN5b9620b9-1660-4b35-b700-6b1347ed9ecb2
198191ranitidine 150 MG Oral TabletSCD5b9620b9-1660-4b35-b700-6b1347ed9ecb2
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY5b9620b9-1660-4b35-b700-6b1347ed9ecb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-316-303335803163030 in 1 BOTTLEHistorical