FDA.reportPublic FDA data

Acid Reducer

Product NDC
55315-351
11-digit product format
553150351
Labeler code
55315
Product ID
55315-351_628e9778-4502-45f3-87d8-9a45388ae666
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Fred's Inc.
Application
ANDA200536
Marketing category
ANDA
Marketing start
2012-03-30
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 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
55315-351-502020-01-31C16284748780-19d75b9d0-3163-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55315-351-50Acid Reducer50 in 1 BOTTLETABLET502
55315-351-50Acid Reducer1 in 1 CARTONTABLET12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2
RANITIDINEACTIVE MOIETY884KT10YB7ACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-351ACID REDUCER (RANITIDINE) TABLET [FRED'S INC.]2Legacy NDC, 2 package rows20140423_f36b1ba7-7553-48ab-8731-29e193522cce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNf36b1ba7-7553-48ab-8731-29e193522cce2
198191ranitidine 150 MG Oral TabletSCDf36b1ba7-7553-48ab-8731-29e193522cce2
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYf36b1ba7-7553-48ab-8731-29e193522cce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55315-351-505531503515050 in 1 BOTTLEHistorical