Ranitidine

Product NDC
17856-0727
11-digit product format
178560727
Labeler code
17856
Product ID
17856-0727_4ca3b7ed-3b83-4209-916d-99a17dfaab3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA077405
Marketing category
ANDA
Marketing start
2009-09-19
Marketing end
0000-00-00
Substance
RANITIDINE
Active strength
15 mg/mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
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
17856-0727-42020-01-31C16284748780-19d75b9d0-a504-f424-e053-dadaa90a57ceRanitidine Syrup (Ranitidine Oral Solution USP)
17856-0727-92020-01-31C16284748780-19d75b9d0-a504-f424-e053-dadaa90a57ceRanitidine Syrup (Ranitidine Oral Solution USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0727-4Ranitidine5 mL in 1 CUPSOLUTION53
17856-0727-9Ranitidine10 mL in 1 CUPSOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0727RANITIDINE SOLUTION [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 2 package rows20160829_361f8a7e-eeba-4941-9868-eaffbc04ba7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705610ranitidine 15 MG/ML Oral SolutionSCD361f8a7e-eeba-4941-9868-eaffbc04ba7e3
705610ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral SolutionSY361f8a7e-eeba-4941-9868-eaffbc04ba7e3
705610ranitidine 75 MG per 5 ML SyrupSY361f8a7e-eeba-4941-9868-eaffbc04ba7e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0727-4178560727045 mL in 1 CUP5 mlHistorical
17856-0727-91785607270910 mL in 1 CUP10 mlHistorical