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 26 of 71 · 1,408 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Mixed Berry Antacid HBG 54ctCALCIUM CARBONATECVS Pharmacye9204edb-e4d9-3975-e053-2995a90ac6a92025-12-07WarningsExact identifier
unii: 92RU3N3Y1O
CVS Mixed Berry Antacid HBG 28ctCALCIUM CARBONATECVS Pharmacye9481d36-3b28-5caf-e053-2a95a90a31212025-12-07WarningsExact identifier
unii: 92RU3N3Y1O
Basic Care Berry Antacid HBGCALCIUM CARBONATEAmazon.comc8d4050e-75fd-2445-e053-2995a90a7b0d2025-12-05WarningsExact identifier
unii: 92RU3N3Y1O
CVS Health Maximum StrengthANTACID AND ANTIGASCVS Pharmacy,Inc.0a13ac81-0c63-48c1-bbb0-f6e67f97b8962025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Quality Choice Infants Dye Free Gas ReliefSIMETHICONECHAIN DRUG MARKETING ASSOCIATION6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e42025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Prequel Skin Utility Balm Multi-Purpose Skin ProtectantSKIN PROTECTANT BALMThe Center Brands, LLC57c0b71d-6099-415c-976d-b96d2f73e9d32025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Alka-Seltzer Kids Tummy ReliefChewsCALCIUM CARBONATE AND DIMETHICONEBayer HealthCare LLC.ba48966e-3762-5fdf-e053-2995a90aeb3d2025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Softlips CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybececc42-1321-430a-80ef-438060fdcc862025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
Gold Bond Diabetics Dry Skin Relief Foot CreamDIMETHICONE AND WHITE PETROLATUMGold Bond Co LLC77b8c30b-d5ba-42ce-9313-4ce1b0bce8732025-12-04WarningsExact identifier
unii: 92RU3N3Y1O
AntiflatulentSIMETHICONEMajor Pharmaceuticalsd321114e-09ac-4252-a6e6-3dbc3a451ee62025-12-03WarningsExact identifier
unii: 92RU3N3Y1O
QC Gas Relief Mint FlavorSIMETHICONEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)26b83259-744b-4711-a32f-9f8fe5d0555b2025-12-03WarningsExact identifier
unii: 92RU3N3Y1O
Walgreens Infants Dye Free Gas ReliefSIMETHICONEWALGREEN CO.05d2a37f-f47d-40e6-a799-120d846bf5d62025-12-02WarningsExact identifier
unii: 92RU3N3Y1O
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEABM Private Limited37b0535d-6bcf-2d40-e063-6294a90a2a8e2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Pediadermics eczema 3COLLOIDAL OATMEAL, DIMETHICONERenu Laboratories, LLCaf861f0b-4387-6861-e053-2995a90a8bfa2025-12-02WarningsExact identifier
unii: 92RU3N3Y1O
Quality Choice Gas Relief Extra Strength SoftgelsSIMETHICONEChain Drug Marketing Association849802d6-698d-479b-9036-781317a59ade2025-12-02WarningsExact identifier
unii: 92RU3N3Y1O
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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