FDA.reportPublic FDA data

Acid Reducer

Product NDC
61715-089
11-digit product format
617150089
Labeler code
61715
Product ID
61715-089_9dacb085-8749-43cc-9bb9-18629c24f6c9
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Plus (Kinray)
Application
ANDA200536
Marketing category
ANDA
Marketing start
2014-01-27
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61715-089-242025-06-02C16284748780-19d75b9d0-1d9e-f424-e053-dadaa90a57ce7d1af7eb-b73f-4980-a321-f8a04075df41
61715-089-242020-01-31C16284748780-19d75b9d0-1d9e-f424-e053-dadaa90a57ce7d1af7eb-b73f-4980-a321-f8a04075df41

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1
RANITIDINEACTIVE MOIETY884KT10YB7ACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1
TALCINACTIVE INGREDIENT7SEV7J4R1UACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61715-089ACID REDUCER (RANITIDINE) TABLET [PREFERRED PLUS (KINRAY)]1Legacy NDC20140131_7d1af7eb-b73f-4980-a321-f8a04075df41.zip