Ranitidine

Product NDC
50436-6942
11-digit product format
504366942
Labeler code
50436
Product ID
50436-6942_1beb5243-839a-4ca9-9ab5-5931a22146c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA078542
Marketing category
ANDA
Marketing start
2008-11-19
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6942-1Ranitidine30 in 1 BOTTLETABLET, FILM COATED3012
50436-6942-3Ranitidine90 in 1 BOTTLETABLET, FILM COATED9012
50436-6942-4Ranitidine60 in 1 BOTTLETABLET, FILM COATED6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6942-1EA - Each50436-69428d1dfe35-7c0a-4885-96ed-6aed06244ecf12014-11-05
50436-6942-3EA - Each50436-6942bed19b42-350c-40f4-9dff-5c441271b9a612014-12-01
50436-6942-4EA - Each50436-6942587dc141-b4c6-4f21-9ccd-3247ca44254c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
TRIACETININACTIVE INGREDIENTXHX3C3X673RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6942RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]12Legacy NDC, 3 package rows20190531_0edf8afb-4af8-4dc9-8d9d-7f233f442736.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198193ranitidine 300 MG Oral TabletPSN0edf8afb-4af8-4dc9-8d9d-7f233f44273612
198193ranitidine 300 MG Oral TabletSCD0edf8afb-4af8-4dc9-8d9d-7f233f44273612
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY0edf8afb-4af8-4dc9-8d9d-7f233f44273612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6942-15043669420130 in 1 BOTTLEHistorical
50436-6942-35043669420390 in 1 BOTTLEHistorical
50436-6942-45043669420460 in 1 BOTTLEHistorical