Ranitidine

Product NDC
67296-1586
11-digit product format
672961586
Labeler code
67296
Product ID
67296-1586_d61c14b0-7134-21ce-e053-2a95a90af133
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
SYRUP
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA077405
Marketing category
ANDA
Marketing start
2018-01-01
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
No
Listing certified through
2023-12-31
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
67296-1586-62024-01-30C16284748780-11030e365-6e92-111a-e063-dadaa90a10e2ranitidine soln

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1586-6Ranitidine60 mL in 1 BOTTLESYRUP604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1586RANITIDINE SYRUP [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20220122_6a10f978-be03-1362-e053-2991aa0a4c1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705610ranitidine 15 MG/ML Oral SolutionSCD6a10f978-be03-1362-e053-2991aa0a4c1f4
705610ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral SolutionSY6a10f978-be03-1362-e053-2991aa0a4c1f4
705610ranitidine 75 MG per 5 ML SyrupSY6a10f978-be03-1362-e053-2991aa0a4c1f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1586-66729615860660 mL in 1 BOTTLE (67296-1586-6) 60 ml2018-01-010000-00-00NoNoCurrent