Ranitidine

Product NDC
63941-352
11-digit product format
639410352
Labeler code
63941
Product ID
63941-352_c369afdb-43ba-482b-a051-83c42c09a64a
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Valu Merchandisers Company
Application
ANDA201745
Marketing category
ANDA
Marketing start
2012-07-10
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
63941-352-302020-01-31C16284748780-19d75b9d0-88de-f424-e053-dadaa90a57ceDrug Facts
63941-352-602020-01-31C16284748780-19d75b9d0-88de-f424-e053-dadaa90a57ceDrug Facts
63941-352-692020-01-31C16284748780-19d75b9d0-88de-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-352-30Ranitidine30 in 1 BOTTLETABLET, FILM COATED301
63941-352-60Ranitidine60 in 1 BOTTLETABLET, FILM COATED601
63941-352-69Ranitidine10 in 1 BLISTER PACKTABLET, FILM COATED101

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-352RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [VALU MERCHANDISERS COMPANY]1Legacy NDC, 3 package rows20130219_3df3e0ca-3e78-447c-b650-82bf11110c01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSN3df3e0ca-3e78-447c-b650-82bf11110c011
312773ranitidine 75 MG Oral TabletSCD3df3e0ca-3e78-447c-b650-82bf11110c011
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY3df3e0ca-3e78-447c-b650-82bf11110c011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63941-352-306394103523030 in 1 BOTTLEHistorical
63941-352-606394103526060 in 1 BOTTLEHistorical
63941-352-696394103526910 in 1 BLISTER PACKHistorical