FDA.reportPublic FDA data

Ranitidine

Product NDC
55111-404
11-digit product format
551110404
Labeler code
55111
Product ID
55111-404_c47f1d10-c4d9-5df4-84e8-55956b47568b
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078192
Marketing category
ANDA
Marketing start
2009-12-02
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
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 HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBK76465IHM
Rxcui198191

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
55111-404-34EA - Each55111-40477f8c9e5-f9d2-4d80-88c6-7059a252ae0612015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ranitidine HydrochlorideACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]6
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61URANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6RANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]6
magnesium stearateINACTIVE INGREDIENT70097M6I30RANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-404RANITIDINE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]11Current NDC, Legacy NDC20200422_00df8a42-296f-80dd-98af-ee8b30eb38cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN00df8a42-296f-80dd-98af-ee8b30eb38cc12
198191ranitidine 150 MG Oral TabletSCD00df8a42-296f-80dd-98af-ee8b30eb38cc12
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY00df8a42-296f-80dd-98af-ee8b30eb38cc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-404-02551110404021 BOTTLE in 1 CARTON (55111-404-02) / 200 TABLET, COATED in 1 BOTTLE1 bottle2009-12-020000-00-00NoNoCurrent
55111-404-17551110404171 BLISTER PACK in 1 CARTON (55111-404-17) / 8 TABLET, COATED in 1 BLISTER PACK1 blister pack2009-12-020000-00-00NoNoCurrent
55111-404-24551110404243 BLISTER PACK in 1 CARTON (55111-404-24) / 8 TABLET, COATED in 1 BLISTER PACK3 blister pack2009-12-020000-00-00NoNoCurrent
55111-404-32551110404321 BOTTLE in 1 CARTON (55111-404-32) / 32 TABLET, COATED in 1 BOTTLE1 bottle2009-12-020000-00-00NoNoCurrent
55111-404-34551110404341 BOTTLE in 1 CARTON (55111-404-34) / 24 TABLET, COATED in 1 BOTTLE1 bottle2009-12-020000-00-00NoNoCurrent
55111-404-36551110404361 BOTTLE in 1 CARTON (55111-404-36) / 36 TABLET, COATED in 1 BOTTLE1 bottle2009-12-020000-00-00NoNoCurrent
55111-404-38551110404384 BLISTER PACK in 1 CARTON (55111-404-38) / 8 TABLET, COATED in 1 BLISTER PACK4 blister pack2009-12-020000-00-00NoNoCurrent
55111-404-40551110404401 BOTTLE in 1 BOTTLE (55111-404-40) / 40 TABLET, COATED in 1 BOTTLE1 bottle2009-12-020000-00-00NoNoCurrent
55111-404-50551110404501 BOTTLE in 1 CARTON (55111-404-50) / 50 TABLET, COATED in 1 BOTTLE1 bottle2009-12-020000-00-00NoNoCurrent
55111-404-55551110404552 BOTTLE in 1 CARTON (55111-404-55) / 65 TABLET, COATED in 1 BOTTLE2 bottle2010-01-050000-00-00NoNoCurrent
55111-404-61551110404611 BOTTLE in 1 CARTON (55111-404-61) / 65 TABLET, COATED in 1 BOTTLE1 bottle2009-12-020000-00-00NoNoCurrent
55111-404-62551110404621 BOTTLE in 1 CARTON (55111-404-62) / 95 TABLET, COATED in 1 BOTTLE1 bottle2009-12-020000-00-00NoNoCurrent
55111-404-65551110404651 BOTTLE in 1 CARTON (55111-404-65) / 220 TABLET, COATED in 1 BOTTLE1 bottle2009-12-020000-00-00NoNoCurrent
55111-404-90551110404902 BOTTLE in 1 CARTON (55111-404-90) / 95 TABLET, COATED in 1 BOTTLE2 bottle2009-12-020000-00-00NoNoCurrent