RANITIDINE

Product NDC
64679-907
11-digit product format
646790907
Labeler code
64679
Product ID
64679-907_76bec459-49be-4132-843c-6f471dab81a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA075208
Marketing category
ANDA
Marketing start
1998-12-17
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
No
Listing certified through
2020-12-31
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-907-01EA - Each64679-9077044d336-682e-439f-8553-5b2ee9d6ab9b12012-07-24
64679-907-02EA - Each64679-907d0ad0f33-19ae-4255-bbf0-43f9ce4438db12012-07-24
64679-907-04EA - Each64679-907d9dbe764-5094-4243-8d7f-6e273e5546fb12012-07-24
64679-907-08EA - Each64679-9073ac966b9-c198-4832-8281-51587cd4349f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GRANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1URANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [STAT RX USA LLC]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [STAT RX USA LLC]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GRANITIDINE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [STAT RX USA LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET [STAT RX USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [STAT RX USA LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1URANITIDINE TABLET [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN7de06786-bf44-4928-aa69-47ab71f276332
198193ranitidine 300 MG Oral TabletPSN7de06786-bf44-4928-aa69-47ab71f276332
198191ranitidine 150 MG Oral TabletSCD7de06786-bf44-4928-aa69-47ab71f276332
198193ranitidine 300 MG Oral TabletSCD7de06786-bf44-4928-aa69-47ab71f276332
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY7de06786-bf44-4928-aa69-47ab71f276332
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY7de06786-bf44-4928-aa69-47ab71f276332
198193ranitidine 300 MG Oral TabletPSN58de82fc-98f8-40ef-8de6-25324451848b1
198193ranitidine 300 MG Oral TabletSCD58de82fc-98f8-40ef-8de6-25324451848b1
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY58de82fc-98f8-40ef-8de6-25324451848b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-907-016467909070130 TABLET in 1 BOTTLE (64679-907-01) 30 tablet1998-12-170000-00-00NoNoCurrent
64679-907-0264679090702250 TABLET in 1 BOTTLE (64679-907-02) 250 tablet1998-12-170000-00-00NoNoCurrent
64679-907-036467909070310 BLISTER PACK in 1 CARTON (64679-907-03) > 10 TABLET in 1 BLISTER PACK10 blister pack1998-12-170000-00-00NoNoCurrent
64679-907-0464679090704100 TABLET in 1 BOTTLE (64679-907-04) 100 tablet1998-12-170000-00-00NoNoCurrent
64679-907-08646790907087500 TABLET in 1 DRUM (64679-907-08) 7500 tablet1998-12-170000-00-00NoNoCurrent
64679-907-09646790907093750 TABLET in 1 DRUM (64679-907-09) 3750 tablet1998-12-170000-00-00NoNoCurrent