FDA.reportPublic FDA data

Ranitidine

Product NDC
21695-110
11-digit product format
216950110
Labeler code
21695
Product ID
21695-110_dcee67ac-e58c-4050-ad16-f8253a17036b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-12-17
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
E
Listing certified through
2017-12-31
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
21695-110-152019-09-24C16284748780-1934fe258-4b33-48b1-e053-8cdaa90a720aRanitidine Tablets, USP
21695-110-302019-09-24C16284748780-1934fe258-4b33-48b1-e053-8cdaa90a720aRanitidine Tablets, USP
21695-110-602019-09-24C16284748780-1934fe258-4b33-48b1-e053-8cdaa90a720aRanitidine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-110-15Ranitidine15 in 1 BOTTLETABLET151
21695-110-30Ranitidine30 in 1 BOTTLETABLET301
21695-110-60Ranitidine60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-110-15EA - Each21695-110568fa570-a79e-44c7-8e67-a999e9374b7412012-07-24
21695-110-30EA - Each21695-1101eb39e09-155e-4bca-bdb4-d3de698d013f12012-07-24
21695-110-60EA - Each21695-1107a2569c7-87ac-46e6-993c-8e2f810fd7fe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-110RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]1Legacy NDC, 3 package rows20100216_a9fef8f6-b823-4b8a-84b8-2b916374adb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNa9fef8f6-b823-4b8a-84b8-2b916374adb51
198193ranitidine 300 MG Oral TabletPSNa9fef8f6-b823-4b8a-84b8-2b916374adb51
198191ranitidine 150 MG Oral TabletSCDa9fef8f6-b823-4b8a-84b8-2b916374adb51
198193ranitidine 300 MG Oral TabletSCDa9fef8f6-b823-4b8a-84b8-2b916374adb51
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYa9fef8f6-b823-4b8a-84b8-2b916374adb51
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYa9fef8f6-b823-4b8a-84b8-2b916374adb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-110-152169501101515 in 1 BOTTLEHistorical
21695-110-302169501103030 in 1 BOTTLEHistorical
21695-110-602169501106060 in 1 BOTTLEHistorical