Ranitidine

Product NDC
50436-0727
11-digit product format
504360727
Labeler code
50436
Product ID
50436-0727_2bfa140c-ef83-4762-abf8-c6ae13ae388a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANITIDINE
Dosage form
SYRUP
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077405
Marketing category
ANDA
Marketing start
2010-11-01
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
15 mg/mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
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
50436-0727-12020-01-31C16284748780-19d75b9d0-ab67-f424-e053-dadaa90a57ceRanitidine Syrup (Ranitidine Oral Solution USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0727-1Ranitidine1 mL in 1 BOTTLESYRUP12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0727RANITIDINE SYRUP [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20180620_817c4a6c-a89c-4d86-87a3-895bbc8fb4ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705610ranitidine 15 MG/ML Oral SolutionSCD817c4a6c-a89c-4d86-87a3-895bbc8fb4ad2
705610ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral SolutionSY817c4a6c-a89c-4d86-87a3-895bbc8fb4ad2
705610ranitidine 75 MG per 5 ML SyrupSY817c4a6c-a89c-4d86-87a3-895bbc8fb4ad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-0727-1504360727011 mL in 1 BOTTLE1 mlHistorical