Ranitidine

Product NDC
0440-2300
11-digit product format
004402300
Labeler code
0440
Product ID
0440-2300_96b79fbb-56cb-4338-8c37-3150d381782e
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA200172
Marketing category
ANDA
Marketing start
2013-07-15
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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
0440-2300-602020-01-31C16284748780-19d75b9d0-e12e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-2300-60Ranitidine60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-2300-60EA - Each0440-230014be2e14-2c7b-4460-94cc-12a8cc52385412014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZRANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IERANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
VANILLININACTIVE INGREDIENTCHI530446XRANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-2300RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20131204_14710d5d-16e8-48f8-9fd5-1530a087eb34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN14710d5d-16e8-48f8-9fd5-1530a087eb341
198191ranitidine 150 MG Oral TabletSCD14710d5d-16e8-48f8-9fd5-1530a087eb341
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY14710d5d-16e8-48f8-9fd5-1530a087eb341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-2300-600044023006060 in 1 BOTTLE, PLASTICHistorical