Ranitidine

Product NDC
68462-249
11-digit product format
684620249
Labeler code
68462
Product ID
68462-249_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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-249-01EA - Each68462-2499950f503-9617-4886-a206-d02582d7cb3b12012-07-24
68462-249-20EA - Each68462-249a824fd7e-db2d-416f-9ca8-7aa38a3a1e1b12012-07-24
68462-249-30EA - Each68462-2496c2132b1-978b-4bb0-b973-f50a28becfd812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5
TRIACETININACTIVE INGREDIENTXHX3C3X673RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198193ranitidine 300 MG Oral TabletPSN0edf8afb-4af8-4dc9-8d9d-7f233f44273612
198193ranitidine 300 MG Oral TabletSCD0edf8afb-4af8-4dc9-8d9d-7f233f44273612
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY0edf8afb-4af8-4dc9-8d9d-7f233f44273612
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
198193ranitidine 300 MG Oral TabletPSN75b0e4f3-57df-44d4-88cc-e5141b458e711
198193ranitidine 300 MG Oral TabletPSN5a1cf9b3-6ad2-0805-e053-2991aa0ab8371
198191ranitidine 150 MG Oral TabletSCD5a1cf9b3-6ad2-0805-e053-2991aa0ab8371
198193ranitidine 300 MG Oral TabletSCD75b0e4f3-57df-44d4-88cc-e5141b458e711
198193ranitidine 300 MG Oral TabletSCD5a1cf9b3-6ad2-0805-e053-2991aa0ab8371
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY5a1cf9b3-6ad2-0805-e053-2991aa0ab8371
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY75b0e4f3-57df-44d4-88cc-e5141b458e711
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
68462-249-0168462024901100 TABLET, FILM COATED in 1 BOTTLE (68462-249-01) 2008-11-190000-00-00NoNoCurrent
68462-249-2068462024920250 TABLET, FILM COATED in 1 BOTTLE (68462-249-20) 2008-11-190000-00-00NoNoCurrent
68462-249-306846202493030 TABLET, FILM COATED in 1 BOTTLE (68462-249-30) 2008-11-190000-00-00NoNoCurrent