Ranitidine

Product NDC
66116-518
11-digit product format
661160518
Labeler code
66116
Product ID
66116-518_b499b520-e7d8-4a21-8ff1-222925577d38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA075165
Marketing category
ANDA
Marketing start
1997-09-12
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
66116-518-602019-11-27C16284748780-19855d018-dc04-cd31-e053-dbdaa90ab51aRanitidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-518-60Ranitidine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMRANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-518RANITIDINE TABLET, FILM COATED [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130820_b499b520-e7d8-4a21-8ff1-222925577d38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNb499b520-e7d8-4a21-8ff1-222925577d381
198191ranitidine 150 MG Oral TabletSCDb499b520-e7d8-4a21-8ff1-222925577d381
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYb499b520-e7d8-4a21-8ff1-222925577d381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-518-606611605186060 in 1 BOTTLEHistorical