FDA.reportPublic FDA data

NDC 55111-575-11 - Ibandronate sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55111-575
Requested NDC
55111-575-11
Package NDCs from labels
55111-575-11, 55111-575-03, 55111-575-13, 55111-575-43
Manufacturer
Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO III
Effective date
2026-02-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibandronate sodium - Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO IIIDr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO III2026-02-16HUMAN PRESCRIPTION DRUG LABEL
Ibandronate sodium - A-S Medication SolutionsA-S Medication Solutions2025-09-22HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 144 · 2,863 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
IBANDRONATE SODIUMIBANDRONATE SODIUMBionpharma Inc.6ca94cce-a2bb-421f-bd8f-6b14bc2bd9852026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 904932
unii: J12U072QL0
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIAShenzhen Finona Information Technology Co., Ltd3874ec89-0f1d-87b9-e063-6394a90a300a2026-08-24WarningsExact identifier
unii: 5138Q19F1X
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.