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 12 of 71 · 1,408 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Sinus DefenseLAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC9c2f51c5-aa41-414e-a966-32e02e9e79a22026-04-02WarningsExact identifier
unii: ETJ7Z6XBU4
Gas Relief Extra StrengthSIMETHICONEH E Bc153585f-0f44-40ad-8246-5d9edae8325e2026-04-02WarningsExact identifier
unii: 92RU3N3Y1O
ultra strength gas reliefSIMETHICONEBIONPHARMA INC.4e6ac834-9ce3-1b54-e063-6294a90a9dff2026-04-01WarningsExact identifier
unii: 92RU3N3Y1O
Zinc oxide, DimethiconeZINC OXIDE, DIMETHICONEWalmart Inc.4cbf9492-33cd-e6d4-e063-6294a90ab0012026-03-31Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: ETJ7Z6XBU4
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corped63df26-3879-46df-8e09-10be569b25be2026-03-31WarningsExact identifier
unii: 92RU3N3Y1O
3M Cavilon Durable BarrierDIMETHICONESolventum US LLCf3f8be33-4ad2-4f5f-ac94-ddfbe0280b832026-03-31WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas Relief CherrySIMETHICONEGood Sense (Geiss, Destin & Dunn, Inc.)91f72cf2-297d-48db-8f05-f8a7050d92e82026-03-31WarningsExact identifier
unii: 92RU3N3Y1O
LymphoplexMYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEABioActive Nutritional, Inc.624f35db-291e-4e7f-a2c9-ae319717157a2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
Equisetum SiliceaEQUISETUM SILICEAUriel Pharmacy Inc.e88b820b-4a07-42e2-8fe2-b30729e91a8c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
B Force HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEABioActive Nutritional, Inc.811c6f32-fcad-464c-bcf6-ae6a59195b1c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
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.c512f211-f4f8-46f6-87ed-dd50287359df2026-03-27WarningsExact identifier
unii: ETJ7Z6XBU4
Extra Strength Gas ReliefSIMETHICONEHyvee Inc44ea37b1-8cd2-936d-e063-6394a90a2be72026-03-27WarningsExact identifier
unii: 92RU3N3Y1O
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corp256dfcfc-a91c-49b0-9439-452586a0880e2026-03-27WarningsExact identifier
unii: 92RU3N3Y1O
Sween 24DIMETHICONEColoplast Corpa623c8d7-8db0-410a-9980-02ac02f7b6ea2026-03-27WarningsExact identifier
unii: 92RU3N3Y1O
Baza Cleanse and Protect Odor ControlDIMETHICONEColoplast Corpca5fa4ae-c18d-4457-b520-4a9318ea821f2026-03-27WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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