Ranitidine

Product NDC
55111-131
11-digit product format
551110131
Labeler code
55111
Product ID
55111-131_210e3c0b-be93-aa50-550d-e383e7d5f19e
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA075294
Marketing category
ANDA
Marketing start
2000-03-01
Substance
RANITIDINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ranitidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANITIDINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBK76465IHM
Rxcui312773

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
55111-131-042025-05-27C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-142025-05-27C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-302025-05-27C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-372025-05-27C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-452025-05-27C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-602025-05-27C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-792025-05-27C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-802025-05-27C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-812025-05-27C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-902025-05-27C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-042025-01-30C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-142025-01-30C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-302025-01-30C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-372025-01-30C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-452025-01-30C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-602025-01-30C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-792025-01-30C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-802025-01-30C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-812025-01-30C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts
55111-131-902025-01-30C16284748780-12cef2736-a539-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-131-60EA - Each55111-1310f78e0cf-e93c-462a-ac98-19f5df90981412018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ranitidine hydrochlorideACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]6
ranitidineACTIVE MOIETY884KT10YB7RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]6
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]6
magnesium stearateINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]6
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ARANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-131RANITIDINE TABLET [DR. REDDY'S LABORATORIES LIMITED]11Current NDC, Legacy NDC20250529_12a38e29-130c-6d41-1753-acccb0b41efe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSN12a38e29-130c-6d41-1753-acccb0b41efe11
312773ranitidine 75 MG Oral TabletSCD12a38e29-130c-6d41-1753-acccb0b41efe11
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY12a38e29-130c-6d41-1753-acccb0b41efe11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-131-04551110131041 BOTTLE in 1 CARTON (55111-131-04) / 120 TABLET in 1 BOTTLE1 bottle2000-03-010000-00-00NoNoCurrent
55111-131-14551110131142 BLISTER PACK in 1 CARTON (55111-131-14) / 10 TABLET in 1 BLISTER PACK2 blister pack2000-03-010000-00-00NoNoCurrent
55111-131-30551110131301 BOTTLE in 1 CARTON (55111-131-30) / 30 TABLET in 1 BOTTLE1 bottle2000-03-010000-00-00NoNoCurrent
55111-131-37551110131371 BOTTLE in 1 CARTON (55111-131-37) / 160 TABLET in 1 BOTTLE1 bottle2000-03-010000-00-00NoNoCurrent
55111-131-45551110131451 BOTTLE in 1 CARTON (55111-131-45) / 45 TABLET in 1 BOTTLE1 bottle2000-03-010000-00-00NoNoCurrent
55111-131-60551110131601 BOTTLE in 1 CARTON (55111-131-60) / 60 TABLET in 1 BOTTLE1 bottle2000-03-010000-00-00NoNoCurrent
55111-131-79551110131791 BLISTER PACK in 1 CARTON (55111-131-79) / 10 TABLET in 1 BLISTER PACK1 blister pack2000-03-010000-00-00NoNoCurrent
55111-131-80551110131801 BOTTLE in 1 CARTON (55111-131-80) / 80 TABLET in 1 BOTTLE1 bottle2000-03-010000-00-00NoNoCurrent
55111-131-81551110131813 BLISTER PACK in 1 CARTON (55111-131-81) / 10 TABLET in 1 BLISTER PACK3 blister pack2000-03-010000-00-00NoNoCurrent
55111-131-90551110131901 BOTTLE in 1 CARTON (55111-131-90) / 90 TABLET in 1 BOTTLE1 bottle2000-03-010000-00-00NoNoCurrent