Ranitidine

Product NDC
59779-356
11-digit product format
597790356
Labeler code
59779
Product ID
59779-356_f1bdb38f-d139-442c-ba58-6fb3bcd0a4b8
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy, Inc
Application
ANDA201745
Marketing category
ANDA
Marketing start
2013-09-19
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
59779-356-082020-01-31C16284748780-19d75b9d0-57c4-f424-e053-dadaa90a57ceDrug Facts
59779-356-162020-01-31C16284748780-19d75b9d0-57c4-f424-e053-dadaa90a57ceDrug Facts
59779-356-312020-01-31C16284748780-19d75b9d0-57c4-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-356-08Ranitidine80 in 1 BOTTLETABLET, FILM COATED801
59779-356-08Ranitidine1 in 1 CARTONTABLET, FILM COATED11
59779-356-16Ranitidine1 in 1 CARTONTABLET, FILM COATED11
59779-356-16Ranitidine160 in 1 BOTTLETABLET, FILM COATED1601
59779-356-31Ranitidine1 in 1 CARTONTABLET, FILM COATED11
59779-356-31Ranitidine30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-356RANITIDINE TABLET, FILM COATED [CVS PHARMACY, INC]1Legacy NDC, 6 package rows20130925_0c9ba844-0d5e-4203-88a7-5f9e3a0a671c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSN0c9ba844-0d5e-4203-88a7-5f9e3a0a671c1
312773ranitidine 75 MG Oral TabletSCD0c9ba844-0d5e-4203-88a7-5f9e3a0a671c1
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY0c9ba844-0d5e-4203-88a7-5f9e3a0a671c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
59779-356-085977903560880 in 1 BOTTLEHistorical
59779-356-16597790356161 in 1 CARTONHistorical
59779-356-31597790356311 in 1 CARTONHistorical