Ranitidine

Product NDC
49348-473
11-digit product format
493480473
Labeler code
49348
Product ID
49348-473_7b32dc8d-59e9-4772-8f66-7b22a7b73688
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sunmark
Application
ANDA201745
Marketing category
ANDA
Marketing start
2013-09-20
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
75 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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
49348-473-122020-01-31C16284748780-19d75b9d0-eeb1-f424-e053-dadaa90a57ceDrug Facts
49348-473-442020-01-31C16284748780-19d75b9d0-eeb1-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-473-12Ranitidine1 in 1 CARTONTABLET, FILM COATED11
49348-473-12Ranitidine60 in 1 BOTTLETABLET, FILM COATED601
49348-473-44Ranitidine1 in 1 CARTONTABLET, FILM COATED11
49348-473-44Ranitidine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-473-12EA - Each49348-47365f0a4b2-e5a4-4494-ab33-ebd99199233e12014-04-03
49348-473-44EA - Each49348-473074b316b-810c-452a-b337-8e62690a90dc12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET, FILM COATED [SUNMARK]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET, FILM COATED [SUNMARK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET, FILM COATED [SUNMARK]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET, FILM COATED [SUNMARK]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET, FILM COATED [SUNMARK]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RANITIDINE TABLET, FILM COATED [SUNMARK]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET, FILM COATED [SUNMARK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET, FILM COATED [SUNMARK]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRANITIDINE TABLET, FILM COATED [SUNMARK]1
TALCINACTIVE INGREDIENT7SEV7J4R1URANITIDINE TABLET, FILM COATED [SUNMARK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET, FILM COATED [SUNMARK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-473RANITIDINE TABLET, FILM COATED [SUNMARK]1Legacy NDC, 4 package rows20130920_840a3114-7b29-40f4-b076-376b94f98146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSN840a3114-7b29-40f4-b076-376b94f981461
312773ranitidine 75 MG Oral TabletSCD840a3114-7b29-40f4-b076-376b94f981461
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY840a3114-7b29-40f4-b076-376b94f981461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49348-473-12493480473121 in 1 CARTONHistorical
49348-473-44493480473441 in 1 CARTONHistorical