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 8 of 71 · 1,408 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
Mag-Al PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONECardinal Health 107, LLC08df7403-9ee3-4a43-a151-c1a6ef7a75492026-06-10WarningsExact identifier
unii: 92RU3N3Y1O
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
Gas ReliefSIMETHICONEAmerisourceBergen (Good Neighbor Pharmacy) 4612233bee4db-d4aa-4c72-8eeb-46ff374a92a62026-06-10WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEP & L Development, LLCf4526eba-e6d0-44de-99ea-4af7a6dba1992026-06-10WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
unii: 92RU3N3Y1O
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO18CALC FLUOR, CALC SULF, SILICEA.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d3c1d6-d0ba-5ea7-e063-6394a90a02942026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
Tums Chewy Bites with Gas ReliefCALCIUM CARBONATE AND SIMETHICONEHaleon US Holdings LLC6d7be7e4-4bff-4cfd-bbbe-df412ac9db102026-06-09WarningsExact identifier
unii: 92RU3N3Y1O
SIMETHICONESIMETHICONEYYBA50250112-933c-ffb1-e063-6394a90aaafb2026-06-09WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
unii: 92RU3N3Y1O
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
INFANTS GAS RELIEFSIMETHICONEMollec Inc53705dbc-daca-2214-e063-6294a90a10972026-06-04WarningsExact identifier
unii: 92RU3N3Y1O
Childrens Simethicone DropsCHILDRENS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma6e26ffbe-4c5b-4689-99bc-88b39ed40a252026-06-04WarningsExact identifier
unii: 92RU3N3Y1O
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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