Ranitidine

Product NDC
53329-695
11-digit product format
533290695
Labeler code
53329
Product ID
53329-695_92f91121-229b-4942-b6d6-3d969c23a8fa
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Medline Industries, 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
53329-695-682020-01-31C16284748780-19d75b9d0-b482-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-695-68Ranitidine24 in 1 BLISTER PACKTABLET241

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ARANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1URANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-695RANITIDINE TABLET [MEDLINE INDUSTRIES, INC.]1Legacy NDC, 1 package rows20130326_9b05deaa-4d46-452b-ab74-7bc0b1111bbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN9b05deaa-4d46-452b-ab74-7bc0b1111bbb1
198191ranitidine 150 MG Oral TabletSCD9b05deaa-4d46-452b-ab74-7bc0b1111bbb1
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY9b05deaa-4d46-452b-ab74-7bc0b1111bbb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53329-695-685332906956824 in 1 BLISTER PACKHistorical