Ranitidine

Product NDC
63868-711
11-digit product format
638680711
Labeler code
63868
Product ID
63868-711_1300e024-05f2-4280-aa5f-fbbd17b3b0b8
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
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
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
63868-711-302020-01-31C16284748780-19d75b9d0-5b8a-f424-e053-dadaa90a57ceDrug Facts
63868-711-602020-01-31C16284748780-19d75b9d0-5b8a-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-711-30Ranitidine30 in 1 BOTTLETABLET, FILM COATED301
63868-711-60Ranitidine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-711RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]1Legacy NDC, 2 package rows20120920_012fa171-a486-4029-b68e-f38432fbf8aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSN012fa171-a486-4029-b68e-f38432fbf8aa1
312773ranitidine 75 MG Oral TabletSCD012fa171-a486-4029-b68e-f38432fbf8aa1
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY012fa171-a486-4029-b68e-f38432fbf8aa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-711-306386807113030 in 1 BOTTLEHistorical
63868-711-606386807116060 in 1 BOTTLEHistorical