FDA.reportPublic FDA data

NDC 0469-2602-71 - Myrbetriq

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
0469-2602
Requested NDC
0469-2602-71
Package NDCs from labels
0469-2602-30, 0469-2602-90, 0469-2602-07, 0469-2602-71
Manufacturer
Cardinal Health 107, LLC
Effective date
2025-11-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Myrbetriq - Cardinal Health 107, LLCCardinal Health 107, LLC2025-11-06HUMAN PRESCRIPTION DRUG LABEL
Myrbetriq - REMEDYREPACK INC.REMEDYREPACK INC.2025-07-07HUMAN PRESCRIPTION DRUG LABEL
MyrbetriqAstellas Pharma US, Inc. | Astellas Pharma Inc. | Sumitomo Chemical Company, Limited | Astellas Ireland Co., Ltd. | Delpharm Meppel B.V.2024-08-01HUMAN 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
0469-2602-07Myrbetriq4 in 1 TRAYTABLET, FILM COATED, EXTENDED RE417
0469-2602-07Myrbetriq1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE117
0469-2602-30Myrbetriq1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE117
0469-2602-30Myrbetriq30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3017
0469-2602-90Myrbetriq90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9017
0469-2602-90Myrbetriq1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0469-2602MYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE MYRBETRIQ (MIRABEGRON) GRANULE, FOR SUSPENSION, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]17Current NDC, Legacy NDC, 6 package rows20240820_ba9e9e15-e666-4c56-9271-2e24739cfa2d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0469-2602-07EA - Each0469-2602b9293cdb-ad1d-4c54-b39b-a03361136c8512023-09-05
0469-2602-30EA - Each0469-2602898a775c-d313-4c3e-aee0-02e3e7aaaf2812013-02-13
0469-2602-71EA - Each0469-2602b7fa3f72-78e5-46fd-bce8-7f3c6420aeb312013-02-13
0469-2602-90EA - Each0469-2602af31e57b-7dff-4a4d-95c2-33293f7efd2612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRABEGRONACTIVE INGREDIENTMVR3JL3B2VMYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]5
MIRABEGRONACTIVE MOIETYMVR3JL3B2VMYRBETRIQ (MIRABEGRON) TABLET, FILM COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]5

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 57 of 70 · 1,381 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
C08 CALCIUM METABOLISMABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN DApex Energetics Inc.bd09a34f-1615-09f0-e053-2995a90ac2ef2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
F10 WRMLVAGRIMONY, ALOE VERA, AURUM METALLICUM, AZURITE, BASIL, CALENDULA OFFICINALIS, CARICA PAPAYA, CAYENNE, DAFFODIL, DICENTRA FORMOSA, DIPLACUS AURANTIACUS, HIBISCUS CHINENSIS, HORSE CHESTNUT, HYLOTELEPHIUM TELEPHIUM, LAVANDULA STOECHAS, LILIUM TIGRINUM, MALVA NEGLECTA, MELILOTUS ALBA, NELUMBO NUCIFERA, PHOSPHORUS, PRUNELLA VULGARIS, ROSA LUCIAE, ROSEMARY, SCUTELLARIA LATERIFLORA, SEPIA, SILICEA, THUJA OCCIDENTALIS, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, YELLOW JASMINEApex Energetics Inc.bf020c17-578d-74c4-e053-2995a90a9e7d2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
N01 PROTOMERADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUMApex Energetics Inc.bfc8e049-2f62-31c4-e053-2a95a90a6e162024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
F25 LF-CHNGSAGRIMONY FLOWERApex Energetics Inc.bf3c7a21-0e4e-6395-e053-2a95a90a71562024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
R16 BRONCHIADENOSINE TRIPHOSPHATE, CALCAREA IODATA, CUPRUM METALLICUM, IGNATIA AMARA, PLATINUM METALLICUM, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.c0f759b1-d7f8-12b3-e053-2a95a90a87682024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
N09 BACTEROTOXACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.ba99bb1e-c36f-8bf8-e053-2995a90ac3082024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
DV HPCALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.74bda12d-5e3d-4f52-9e3f-98012c92fc912024-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
GAS RELIEF EXTRA STRENGTHSIMETHICONEYYBA CORPcc79435e-6d4b-b283-e053-2995a90a8db32024-01-03WarningsExact identifier
unii: 92RU3N3Y1O
Childrens Mylicon All in One Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.0952eba8-6de2-4a77-956d-339fab4374722024-01-01WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Maximum Strength Vanilla Caramel FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.ace5cae4-3a78-41c3-987d-59ce22dca2ac2024-01-01WarningsExact identifier
unii: 92RU3N3Y1O
Mylicon Infants Gas Relief OriginalSIMETHICONEInfirst Healthcare395be942-d883-4bcb-8811-6fe1521d5a922024-01-01WarningsExact identifier
unii: 92RU3N3Y1O
Mylicon Infants Gas Relief Dye FreeSIMETHICONEInfirst Healthcare3324139a-ed22-43af-859d-e7af19a24ee92024-01-01WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Coat and CoolCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEINFIRST HEALTHCARE INC.b6571f7f-e1ea-4034-a46c-4de1d01beec32024-01-01WarningsExact identifier
unii: 92RU3N3Y1O
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.22c8f143-1c23-4a10-9577-2adc03f1b6b22023-12-28WarningsExact identifier
unii: ETJ7Z6XBU4
CeraVe Developed with Dermatologists Therapeutic HandDIMETHICONEL'Oreal USA Products Inc7fe49112-4180-415c-a380-768a8d6b21852023-12-28WarningsExact identifier
unii: 92RU3N3Y1O
Equate Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Wal-Mart Stores, Inc.91fb8fb5-b871-4535-e053-2995a90a9b162023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Sunmark Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC043ccc34-44ee-416a-88bc-f247774e90752023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Rite Aid Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Rite Aid Corporationfa1b5b66-9643-e9a7-e053-6394a90ae3cf2023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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