Ranitidine

Product NDC
53808-0775
11-digit product format
538080775
Labeler code
53808
Product ID
53808-0775_23799e22-8ede-40fd-a9cb-a5ba4fd484a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-07-01
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
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
53808-0775-12020-01-31C16284748780-19d75b9d0-7c7e-f424-e053-dadaa90a57ceRanitidine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0775-1Ranitidine30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0775RANITIDINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100415_b85c7258-f5a2-4baa-b2e5-f951da7589e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNb85c7258-f5a2-4baa-b2e5-f951da7589e91
198191ranitidine 150 MG Oral TabletSCDb85c7258-f5a2-4baa-b2e5-f951da7589e91
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYb85c7258-f5a2-4baa-b2e5-f951da7589e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0775-15380807750130 in 1 BLISTER PACKHistorical