Ranitidine

Product NDC
43353-952
11-digit product format
433530952
Labeler code
43353
Product ID
43353-952_1d958be7-19f4-4ad9-929c-409a037bda20
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA200172
Marketing category
ANDA
Marketing start
2013-07-15
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
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
43353-952-712020-01-31C16284748780-19d75b9cf-e9ab-f424-e053-dadaa90a57ceDrug Facts
43353-952-802020-01-31C16284748780-19d75b9cf-e9ab-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-952-71Ranitidine1000 in 1 BOTTLETABLET, FILM COATED10001
43353-952-80Ranitidine180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-952RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20160708_48d5c94c-4806-4b69-92d1-a0fc09ef9c96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN48d5c94c-4806-4b69-92d1-a0fc09ef9c961
198191ranitidine 150 MG Oral TabletSCD48d5c94c-4806-4b69-92d1-a0fc09ef9c961
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY48d5c94c-4806-4b69-92d1-a0fc09ef9c961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-952-71433530952711000 in 1 BOTTLEHistorical
43353-952-8043353095280180 in 1 BOTTLEHistorical