Ranitidine

Product NDC
53217-343
11-digit product format
532170343
Labeler code
53217
Product ID
53217-343_666c4e77-04d8-4266-80c6-6c7b5a2c01b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077824
Marketing category
ANDA
Marketing start
2017-11-21
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
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
53217-343-602020-01-31C16284748780-19d75b9d0-bab5-f424-e053-dadaa90a57ceRanitidine Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-343-60Ranitidine60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-343RANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180815_da16ffa4-7fd1-40b8-a382-eb8421c99220.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNda16ffa4-7fd1-40b8-a382-eb8421c992201
198191ranitidine 150 MG Oral TabletSCDda16ffa4-7fd1-40b8-a382-eb8421c992201
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYda16ffa4-7fd1-40b8-a382-eb8421c992201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-343-605321703436060 in 1 BOTTLEHistorical