FDA.reportPublic FDA data

Zantac 75

Product NDC
68151-2584
11-digit product format
681512584
Labeler code
68151
Product ID
68151-2584_18b916c5-b24f-4855-96f3-881e43be87c5
Type
HUMAN OTC DRUG
Nonproprietary name
ranitidine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA020520
Marketing category
NDA
Marketing start
2006-12-21
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
75 mg/1
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
68151-2584-02020-01-31C16284748780-19d75b9d0-42c1-f424-e053-dadaa90a57ceZantac 75 ® Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2584-0Zantac 751 in 1 PACKAGETABLET, COATED15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ranitidine hydrochlorideACTIVE INGREDIENTBK76465IHMZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
ranitidineACTIVE MOIETY884KT10YB7ZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2584ZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]5Legacy NDC, 1 package rows20171228_6b52d3b3-aca0-450e-985c-0a062d4ab5c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSN6b52d3b3-aca0-450e-985c-0a062d4ab5c25
827183Zantac 75 MG Oral TabletPSN6b52d3b3-aca0-450e-985c-0a062d4ab5c25
827183ranitidine 75 MG Oral Tablet [Zantac]SBD6b52d3b3-aca0-450e-985c-0a062d4ab5c25
312773ranitidine 75 MG Oral TabletSCD6b52d3b3-aca0-450e-985c-0a062d4ab5c25
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY6b52d3b3-aca0-450e-985c-0a062d4ab5c25
827183Zantac 75 75 MG Oral TabletSY6b52d3b3-aca0-450e-985c-0a062d4ab5c25
827183Zantac 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY6b52d3b3-aca0-450e-985c-0a062d4ab5c25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2584-0681512584001 in 1 PACKAGEHistorical