Ranitidine

Product NDC
62011-0225
11-digit product format
620110225
Labeler code
62011
Product ID
62011-0225_210820c3-6696-458a-ab49-6933aa23a9f2
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Health Mart
Application
ANDA201745
Marketing category
ANDA
Marketing start
2013-09-20
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
62011-0225-12020-01-31C16284748780-19d75b9d0-3e7a-f424-e053-dadaa90a57ceDrug Facts
62011-0225-22020-01-31C16284748780-19d75b9d0-3e7a-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0225-1Ranitidine30 in 1 BOTTLETABLET, FILM COATED301
62011-0225-1Ranitidine1 in 1 CARTONTABLET, FILM COATED11
62011-0225-2Ranitidine60 in 1 BOTTLETABLET, FILM COATED601
62011-0225-2Ranitidine1 in 1 CARTONTABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0225-1EA - Each62011-0225679a3a1d-7697-47ec-a013-aeb23dbf9d0f12014-04-03
62011-0225-2EA - Each62011-0225fc6da36f-ee49-4726-b669-5fb32b6a27a712014-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0225RANITIDINE TABLET, FILM COATED [HEALTH MART]1Legacy NDC, 4 package rows20130920_3ef04772-91f4-4a87-8122-fc5d174fd95f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSN3ef04772-91f4-4a87-8122-fc5d174fd95f1
312773ranitidine 75 MG Oral TabletSCD3ef04772-91f4-4a87-8122-fc5d174fd95f1
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY3ef04772-91f4-4a87-8122-fc5d174fd95f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62011-0225-16201102250130 in 1 BOTTLEHistorical
62011-0225-26201102250260 in 1 BOTTLEHistorical