Ranitidine

Product NDC
53217-372
11-digit product format
532170372
Labeler code
53217
Product ID
53217-372_e078fab8-012a-44df-8116-c11691e2c55e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078542
Marketing category
ANDA
Marketing start
2018-04-09
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
300 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
53217-372-302020-01-31C16284748780-19d75b9d0-624a-f424-e053-dadaa90a57ceRanitidine Tablets USP, 300 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-372-30Ranitidine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-372RANITIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180823_75b0e4f3-57df-44d4-88cc-e5141b458e71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198193ranitidine 300 MG Oral TabletPSN75b0e4f3-57df-44d4-88cc-e5141b458e711
198193ranitidine 300 MG Oral TabletSCD75b0e4f3-57df-44d4-88cc-e5141b458e711
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY75b0e4f3-57df-44d4-88cc-e5141b458e711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-372-305321703723030 in 1 BOTTLEHistorical