Ranitidine

Product NDC
46122-223
11-digit product format
461220223
Labeler code
46122
Product ID
46122-223_ace6f559-73e4-4853-a71f-5d3b7cb96031
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA201745
Marketing category
ANDA
Marketing start
2013-09-06
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
46122-223-652020-01-31C16284748780-19d75b9cf-e6f3-f424-e053-dadaa90a57ceDrug Facts
46122-223-722020-01-31C16284748780-19d75b9cf-e6f3-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-223-65Ranitidine30 in 1 BOTTLETABLET, FILM COATED301
46122-223-65Ranitidine1 in 1 CARTONTABLET, FILM COATED11
46122-223-72Ranitidine60 in 1 BOTTLETABLET, FILM COATED601
46122-223-72Ranitidine1 in 1 CARTONTABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-223-65EA - Each46122-223ee64494f-4261-4b1b-b88c-274a81c0f1f312014-05-02
46122-223-72EA - Each46122-2232b500a9c-6aab-40f4-b89b-7af55035912712014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1
TALCINACTIVE INGREDIENT7SEV7J4R1URANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-223RANITIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]1Legacy NDC, 4 package rows20130906_113d3844-0dfa-4ccf-852d-5a0559e52bcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSN113d3844-0dfa-4ccf-852d-5a0559e52bcd1
312773ranitidine 75 MG Oral TabletSCD113d3844-0dfa-4ccf-852d-5a0559e52bcd1
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY113d3844-0dfa-4ccf-852d-5a0559e52bcd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46122-223-654612202236530 in 1 BOTTLEHistorical
46122-223-724612202237260 in 1 BOTTLEHistorical