FDA.reportPublic FDA data

Ranitidine

Product NDC
49035-353
11-digit product format
490350353
Labeler code
49035
Product ID
49035-353_eab45a8e-bc72-42d0-86f9-2eaef2b1e7b3
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores, 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
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
49035-353-302020-01-31C16284748780-19d75b9cf-d5dd-f424-e053-dadaa90a57ceDrug Facts
49035-353-552020-01-31C16284748780-19d75b9cf-d5dd-f424-e053-dadaa90a57ceDrug Facts
49035-353-692020-01-31C16284748780-19d75b9cf-d5dd-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-353-30Ranitidine30 in 1 BOTTLETABLET, FILM COATED302
49035-353-55Ranitidine150 in 1 BOTTLETABLET, FILM COATED1502
49035-353-69Ranitidine10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-353RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [WAL-MART STORES, INC]2Legacy NDC, 3 package rows20150210_f39319e4-f60e-451f-ba5b-a26462db9bf1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSNf39319e4-f60e-451f-ba5b-a26462db9bf12
312773ranitidine 75 MG Oral TabletSCDf39319e4-f60e-451f-ba5b-a26462db9bf12
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSYf39319e4-f60e-451f-ba5b-a26462db9bf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49035-353-304903503533030 in 1 BOTTLEHistorical
49035-353-5549035035355150 in 1 BOTTLEHistorical
49035-353-694903503536910 in 1 BLISTER PACKHistorical