Ranitidine - Acid Reducer

Product NDC
68016-352
11-digit product format
680160352
Labeler code
68016
Product ID
68016-352_f48d12b3-6601-461a-97f0-6b233e5ac724
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Consortium, LLC.
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
68016-352-302020-01-31C16284748780-19d75b9d0-fec5-f424-e053-dadaa90a57ceDrug Facts
68016-352-602020-01-31C16284748780-19d75b9d0-fec5-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-352-30Ranitidine - Acid Reducer30 in 1 BOTTLETABLET, FILM COATED302
68016-352-60Ranitidine - Acid Reducer60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-352-30EA - Each68016-35296386858-4b87-4762-a98b-a5fe5be2756612015-01-05
68016-352-60EA - Each68016-352a17f6661-4fa6-4acb-aa70-5ff761e1454b12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1URANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-352RANITIDINE - ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM, LLC.]2Legacy NDC, 2 package rows20151014_92e1e60c-be24-4b20-8a2a-a39d03cc3cf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSN92e1e60c-be24-4b20-8a2a-a39d03cc3cf32
312773ranitidine 75 MG Oral TabletSCD92e1e60c-be24-4b20-8a2a-a39d03cc3cf32
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY92e1e60c-be24-4b20-8a2a-a39d03cc3cf32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68016-352-306801603523030 in 1 BOTTLEHistorical
68016-352-606801603526060 in 1 BOTTLEHistorical