RANITIDINE

Product NDC
55648-740
11-digit product format
556480740
Labeler code
55648
Product ID
55648-740_f60514be-7bf5-48bb-9a26-e1a70b7e74c1
Type
HUMAN OTC DRUG
Nonproprietary name
RANITIDINE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA078884
Marketing category
ANDA
Marketing start
2008-07-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-740-00RANITIDINE60000 in 1 DRUMTABLET, COATED600001
55648-740-01RANITIDINE10 in 1 BOTTLETABLET, COATED101
55648-740-01RANITIDINE1 in 1 CARTONTABLET, COATED11
55648-740-02RANITIDINE1 in 1 CARTONTABLET, COATED11
55648-740-02RANITIDINE100 in 1 BOTTLETABLET, COATED1001
55648-740-03RANITIDINE10 in 1 BLISTER PACKTABLET, COATED101
55648-740-03RANITIDINE10 in 1 CARTONTABLET, COATED101
55648-740-04RANITIDINE500 in 1 BOTTLETABLET, COATED5001
55648-740-04RANITIDINE1 in 1 CARTONTABLET, COATED11
55648-740-05RANITIDINE10000 in 1 POUCHTABLET, COATED100001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFRANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-740RANITIDINE TABLET, COATED [WOCKHARDT LIMITED]1Legacy NDC, 10 package rows20111122_ff374897-6078-4061-be9c-0b880595ab1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSNff374897-6078-4061-be9c-0b880595ab1f1
312773ranitidine 75 MG Oral TabletSCDff374897-6078-4061-be9c-0b880595ab1f1
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSYff374897-6078-4061-be9c-0b880595ab1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-740-005564807400060000 in 1 DRUMHistorical
55648-740-015564807400110 in 1 BOTTLEHistorical
55648-740-02556480740021 in 1 CARTONHistorical
55648-740-035564807400310 in 1 BLISTER PACKHistorical
55648-740-0455648074004500 in 1 BOTTLEHistorical
55648-740-055564807400510000 in 1 POUCHHistorical