Ranitidine

Product NDC
0440-8305
11-digit product format
004408305
Labeler code
0440
Product ID
0440-8305_3410c954-c270-42cc-975d-90d9a0a9e315
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-12-16
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-8305-00Ranitidine1000 in 1 BOTTLETABLET10001
0440-8305-05Ranitidine500 in 1 BOTTLETABLET5001
0440-8305-20Ranitidine20 in 1 BOTTLETABLET201
0440-8305-30Ranitidine30 in 1 BOTTLETABLET301
0440-8305-60Ranitidine60 in 1 BOTTLETABLET601
0440-8305-81Ranitidine300 in 1 BOTTLETABLET3001
0440-8305-85Ranitidine800 in 1 BOTTLETABLET8001
0440-8305-90Ranitidine90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-8305RANITIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 8 package rows20160729_ae8c3e95-3503-4553-bc58-cc3e0170bcf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNae8c3e95-3503-4553-bc58-cc3e0170bcf81
198191ranitidine 150 MG Oral TabletSCDae8c3e95-3503-4553-bc58-cc3e0170bcf81
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYae8c3e95-3503-4553-bc58-cc3e0170bcf81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-8305-00004408305001000 in 1 BOTTLEHistorical
0440-8305-0500440830505500 in 1 BOTTLEHistorical
0440-8305-200044083052020 in 1 BOTTLEHistorical
0440-8305-300044083053030 in 1 BOTTLEHistorical
0440-8305-600044083056060 in 1 BOTTLEHistorical
0440-8305-8100440830581300 in 1 BOTTLEHistorical
0440-8305-8500440830585800 in 1 BOTTLEHistorical
0440-8305-900044083059090 in 1 BOTTLEHistorical