FDA.reportPublic FDA data

Ranitidine

Product NDC
53746-254
11-digit product format
537460254
Labeler code
53746
Product ID
53746-254_906b462d-e4a3-4f23-8d1b-2605476c40e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-12-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ranitidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANITIDINE HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBK76465IHM
Rxcui198191, 198193

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
53746-254-012021-02-04C16284748780-1ba0f9c33-4f22-a910-e053-dadaa90a0b85Ranitidine Tablets, USP Rx Only
53746-254-022021-02-04C16284748780-1ba0f9c33-4f22-a910-e053-dadaa90a0b85Ranitidine Tablets, USP Rx Only
53746-254-302021-02-04C16284748780-1ba0f9c33-4f22-a910-e053-dadaa90a0b85Ranitidine Tablets, USP Rx Only
53746-254-012021-01-29C16284748780-1ba0f9c33-4f22-a910-e053-dadaa90a0b85Ranitidine Tablets, USP Rx Only
53746-254-022021-01-29C16284748780-1ba0f9c33-4f22-a910-e053-dadaa90a0b85Ranitidine Tablets, USP Rx Only
53746-254-302021-01-29C16284748780-1ba0f9c33-4f22-a910-e053-dadaa90a0b85Ranitidine Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-254-01Ranitidine100 in 1 BOTTLETABLET10021
53746-254-02Ranitidine250 in 1 BOTTLETABLET25021
53746-254-30Ranitidine30 in 1 BOTTLETABLET3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-254-01EA - Each53746-254986caab3-76f1-4de9-8c26-bda817f8e82b12012-07-24
53746-254-02EA - Each53746-2548906af28-9391-4a2a-a518-7aeaca978d3612012-07-24
53746-254-30EA - Each53746-25425e9c2a9-f2e8-482b-a0ed-d2905f7ee2f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [STAT RX USA LLC]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [STAT RX USA LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET [STAT RX USA LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RANITIDINE TABLET [STAT RX USA LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [STAT RX USA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [STAT RX USA LLC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IERANITIDINE TABLET [STAT RX USA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET [STAT RX USA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [STAT RX USA LLC]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMRANITIDINE TABLET [STAT RX USA LLC]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]1
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-254RANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]19Current NDC, Legacy NDC, 3 package rows20230112_b38a3332-5c54-453f-aeb7-070f830955c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNb38a3332-5c54-453f-aeb7-070f830955c221
198193ranitidine 300 MG Oral TabletPSNb38a3332-5c54-453f-aeb7-070f830955c221
198191ranitidine 150 MG Oral TabletSCDb38a3332-5c54-453f-aeb7-070f830955c221
198193ranitidine 300 MG Oral TabletSCDb38a3332-5c54-453f-aeb7-070f830955c221
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYb38a3332-5c54-453f-aeb7-070f830955c221
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYb38a3332-5c54-453f-aeb7-070f830955c221
198191ranitidine 150 MG Oral TabletPSN9add19e6-f71c-4950-ae63-90e152a9cfe07
198193ranitidine 300 MG Oral TabletPSN9add19e6-f71c-4950-ae63-90e152a9cfe07
198191ranitidine 150 MG Oral TabletSCD9add19e6-f71c-4950-ae63-90e152a9cfe07
198193ranitidine 300 MG Oral TabletSCD9add19e6-f71c-4950-ae63-90e152a9cfe07
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY9add19e6-f71c-4950-ae63-90e152a9cfe07
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY9add19e6-f71c-4950-ae63-90e152a9cfe07
198191ranitidine 150 MG Oral TabletPSNa0a40104-2196-4ea2-9577-63b86d6acb653
198193ranitidine 300 MG Oral TabletPSNa0a40104-2196-4ea2-9577-63b86d6acb653
198191ranitidine 150 MG Oral TabletSCDa0a40104-2196-4ea2-9577-63b86d6acb653
198193ranitidine 300 MG Oral TabletSCDa0a40104-2196-4ea2-9577-63b86d6acb653
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYa0a40104-2196-4ea2-9577-63b86d6acb653
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYa0a40104-2196-4ea2-9577-63b86d6acb653
198191ranitidine 150 MG Oral TabletPSNd5962f4c-1cbc-4034-b171-9a35fc75b5462
198193ranitidine 300 MG Oral TabletPSNd5962f4c-1cbc-4034-b171-9a35fc75b5462
198191ranitidine 150 MG Oral TabletSCDd5962f4c-1cbc-4034-b171-9a35fc75b5462
198193ranitidine 300 MG Oral TabletSCDd5962f4c-1cbc-4034-b171-9a35fc75b5462
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYd5962f4c-1cbc-4034-b171-9a35fc75b5462
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYd5962f4c-1cbc-4034-b171-9a35fc75b5462
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-254-0153746025401100 TABLET in 1 BOTTLE (53746-254-01) 100 tablet2009-12-160000-00-00NoNoCurrent
53746-254-0253746025402250 TABLET in 1 BOTTLE (53746-254-02) 250 tablet2009-12-160000-00-00NoNoCurrent
53746-254-305374602543030 TABLET in 1 BOTTLE (53746-254-30) 30 tablet2009-12-160000-00-00NoNoCurrent