Ibandronate sodium

Product NDC
55111-575
11-digit product format
551110575
Labeler code
55111
Product ID
55111-575_eeeb1802-6fe6-ebb0-2df8-98b42385b89f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibandronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078997
Marketing category
ANDA
Marketing start
2012-06-21
Substance
IBANDRONATE SODIUM
Active strength
150 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBANDRONATE SODIUM150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ12U072QL0
Rxcui904932

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fca0fe5b-9e2b-f6fc-e68d-b5f751d08578Product name320180103
a7e2afc7-9184-42ab-b6c6-6edca00dd2d2Product name420160310

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-575-03Ibandronate sodium3 in 1 CARTONTABLET322
55111-575-11Ibandronate sodium1 in 1 BLISTER PACKTABLET122
55111-575-13Ibandronate sodium3 in 1 BLISTER PACKTABLET322
55111-575-43Ibandronate sodium1 in 1 CARTONTABLET122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-575-03EA - Each55111-5750a46e777-4c58-495c-880e-f61177216a6212012-07-24
55111-575-11EA - Each55111-575aa225567-f0ea-40b1-8a83-f58bcad76dfa12013-02-13
55111-575-43EA - Each55111-57556ef791c-9c0c-4a70-b3fd-dedd35828ef612022-02-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ibandronate sodiumACTIVE INGREDIENTJ12U072QL0IBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
IBANDRONIC ACIDACTIVE MOIETYUMD7G2653WIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
AMMONIAINACTIVE INGREDIENT5138Q19F1XIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4IBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48IBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
crospovidoneINACTIVE INGREDIENT68401960MKIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
POVIDONEINACTIVE INGREDIENTFZ989GH94EIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
shellacINACTIVE INGREDIENT46N107B71OIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
sodium stearyl fumarateINACTIVE INGREDIENT7CV7WJK4UIIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPIBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-575IBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]21Current NDC, Legacy NDC, 4 package rows20230531_f94d9c49-245a-8081-42c4-785113fce498.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904932ibandronate sodium 150 MG Oral TabletPSNf94d9c49-245a-8081-42c4-785113fce49822
904932ibandronic acid 150 MG Oral TabletSCDf94d9c49-245a-8081-42c4-785113fce49822
904932ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral TabletSYf94d9c49-245a-8081-42c4-785113fce49822
904932ibandronate sodium 150 MG Oral TabletPSNe5b6c2a9-a55f-41f9-a592-e26ef03e2d731
904932ibandronic acid 150 MG Oral TabletSCDe5b6c2a9-a55f-41f9-a592-e26ef03e2d731
904932ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral TabletSYe5b6c2a9-a55f-41f9-a592-e26ef03e2d731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-575-03551110575033 BLISTER PACK in 1 CARTON (55111-575-03) / 1 TABLET in 1 BLISTER PACK (55111-575-11) 3 blister pack2012-06-210000-00-00NoNoCurrent
55111-575-11551110575111 in 1 BLISTER PACKHistorical
55111-575-13551110575133 in 1 BLISTER PACKHistorical
55111-575-43551110575431 BLISTER PACK in 1 CARTON (55111-575-43) / 3 TABLET in 1 BLISTER PACK (55111-575-13) 1 blister pack2021-11-200000-00-00NoNoCurrent