Ranitidine

Product NDC
68462-248
11-digit product format
684620248
Labeler code
68462
Product ID
68462-248_7d761784-6185-452e-abc9-47344cfd16c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA078542
Marketing category
ANDA
Marketing start
2008-11-19
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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-248-01EA - Each68462-2485264e607-d891-4b2d-814f-c0f2de4f60a112012-07-24
68462-248-05EA - Each68462-24809c64cf3-c532-46fa-a303-a9ea87e5e46112012-07-24
68462-248-60EA - Each68462-24816bd19ab-c6fd-4073-8fe1-dc331266c25612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]2
TRIACETININACTIVE INGREDIENTXHX3C3X673RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARANITIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673RANITIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN80069a62-6022-4070-b466-8d7bbe49dc6f10
198191ranitidine 150 MG Oral TabletSCD80069a62-6022-4070-b466-8d7bbe49dc6f10
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY80069a62-6022-4070-b466-8d7bbe49dc6f10
198191ranitidine 150 MG Oral TabletPSN1153e9d4-e621-4c08-914a-69f0f86918246
198191ranitidine 150 MG Oral TabletSCD1153e9d4-e621-4c08-914a-69f0f86918246
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY1153e9d4-e621-4c08-914a-69f0f86918246
198191ranitidine 150 MG Oral TabletPSNe24b34ec-d779-4c99-a9e9-0a3bdee39f0c2
198193ranitidine 300 MG Oral TabletPSNe24b34ec-d779-4c99-a9e9-0a3bdee39f0c2
198191ranitidine 150 MG Oral TabletSCDe24b34ec-d779-4c99-a9e9-0a3bdee39f0c2
198193ranitidine 300 MG Oral TabletSCDe24b34ec-d779-4c99-a9e9-0a3bdee39f0c2
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYe24b34ec-d779-4c99-a9e9-0a3bdee39f0c2
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYe24b34ec-d779-4c99-a9e9-0a3bdee39f0c2
198191ranitidine 150 MG Oral TabletPSN5a1cf9b3-6ad2-0805-e053-2991aa0ab8371
198191ranitidine 150 MG Oral TabletPSN0fc48144-666d-0baf-e054-00144ff8d46c1
198193ranitidine 300 MG Oral TabletPSN5a1cf9b3-6ad2-0805-e053-2991aa0ab8371
198191ranitidine 150 MG Oral TabletSCD5a1cf9b3-6ad2-0805-e053-2991aa0ab8371
198191ranitidine 150 MG Oral TabletSCD0fc48144-666d-0baf-e054-00144ff8d46c1
198193ranitidine 300 MG Oral TabletSCD5a1cf9b3-6ad2-0805-e053-2991aa0ab8371
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY5a1cf9b3-6ad2-0805-e053-2991aa0ab8371
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY0fc48144-666d-0baf-e054-00144ff8d46c1
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY5a1cf9b3-6ad2-0805-e053-2991aa0ab8371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-248-0168462024801100 TABLET, FILM COATED in 1 BOTTLE (68462-248-01) 2008-11-190000-00-00NoNoCurrent
68462-248-0568462024805500 TABLET, FILM COATED in 1 BOTTLE (68462-248-05) 2008-11-190000-00-00NoNoCurrent
68462-248-606846202486060 TABLET, FILM COATED in 1 BOTTLE (68462-248-60) 2008-11-190000-00-00NoNoCurrent