FDA.reportPublic FDA data

Acid Reducer

Product NDC
50804-352
11-digit product format
508040352
Labeler code
50804
Product ID
50804-352_5013d592-d61d-4096-87f9-4d117e5acb16
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Good Sense
Application
ANDA201745
Marketing category
ANDA
Marketing start
2013-10-11
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
50804-352-082020-01-31C16284748780-19d75b9d0-a1f2-f424-e053-dadaa90a57ceDrug Facts
50804-352-312020-01-31C16284748780-19d75b9d0-a1f2-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-352-08Acid Reducer1 in 1 CARTONTABLET, FILM COATED13
50804-352-08Acid Reducer80 in 1 BOTTLETABLET, FILM COATED803
50804-352-31Acid Reducer10 in 1 BLISTER PACKTABLET, FILM COATED103
50804-352-31Acid Reducer3 in 1 CARTONTABLET, FILM COATED33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-352-31EA - Each50804-35259c3b944-b7b5-40ab-af0a-10a2e7c976e812014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3
RANITIDINEACTIVE MOIETY884KT10YB7ACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3
TALCINACTIVE INGREDIENT7SEV7J4R1UACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-352ACID REDUCER (RANITIDINE) TABLET, FILM COATED [GOOD SENSE]3Legacy NDC, 4 package rows20140108_af34ce45-cb98-46e4-bf73-d9cfb9de9692.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSNaf34ce45-cb98-46e4-bf73-d9cfb9de96923
312773ranitidine 75 MG Oral TabletSCDaf34ce45-cb98-46e4-bf73-d9cfb9de96923
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSYaf34ce45-cb98-46e4-bf73-d9cfb9de96923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50804-352-08508040352081 in 1 CARTONHistorical
50804-352-315080403523110 in 1 BLISTER PACKHistorical