FDA.reportPublic FDA data

NDC 70710-1160-01 - Mirabegron

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
70710-1160
Requested NDC
70710-1160-01
Package NDCs from labels
70710-1160-3, 70710-1160-9, 70710-1160-1, 70710-1160-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mirabegron - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-03HUMAN PRESCRIPTION DRUG LABEL
Mirabegron - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited2024-10-09HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70710-1160-12024-03-04These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012
70710-1160-32024-03-04These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012
70710-1160-92024-03-04These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012
70710-1160-12024-01-30These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012
70710-1160-32024-01-30These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012
70710-1160-92024-01-30These highlights do not include all the information needed to use MIRABEGRON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MIRABEGRON EXTENDED-RELEASE TABLETS MIRABEGRON extended-release tablets, for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1160-1Mirabegron100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
70710-1160-3Mirabegron30 in 1 BOTTLETABLET, EXTENDED RELEASE303
70710-1160-9Mirabegron90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1160MIRABEGRON TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]3Current NDC, 3 package rows20241013_2e40eb74-3b2a-47f7-bf31-fe27484f9bd2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1160-3EA - Each70710-116067a31330-7ccc-41da-930b-5b3c67b0a9e812024-05-16
70710-1160-9EA - Each70710-11600d5e02dd-cd41-4db4-b847-f2eed66a972f12024-05-16

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 4 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
unii: 1K09F3G675
Ferrum rosatum GraphitesFERRUM ROSATUM GRAPHITESUriel Pharmacy Inc.1a4ca338-eada-4c0f-8bce-480244940c892025-06-27WarningsExact identifier
unii: 1K09F3G675
AquavitAQUAVITUriel Pharmacy Inc.c1c0887a-c388-c737-e053-2a95a90a076c2025-06-06WarningsExact identifier
unii: 1K09F3G675
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 1K09F3G675
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDPreferred Pharmaceuticals Inc.326f3d80-c1bf-4cf0-a662-58e02ed7ee672025-02-12Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Prunus IronPRUNUS IRONUriel Pharmacy Inc.091be588-b62e-4919-8e9e-3edb9792d3192025-01-22WarningsExact identifier
unii: 1K09F3G675
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: 1K09F3G675
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 1K09F3G675
MirabegronMIRABEGRONZydus Lifesciences Limited461b2b94-205a-4860-9cb4-d30267ada9df2024-10-09Warnings, Adverse reactionsExact identifier
application number: ANDA209488
rxcui: 1300801
rxcui: 1300791
unii: MVR3JL3B2V
MirabegronMIRABEGRONZydus Pharmaceuticals (USA) Inc.2e40eb74-3b2a-47f7-bf31-fe27484f9bd22024-10-09Warnings, Adverse reactionsExact identifier
application number: ANDA209488
ndc (package): 70710-1159-3
ndc (package): 70710-1159-9
ndc (package): 70710-1159-1
ndc (package): 70710-1160-3
ndc (package): 70710-1160-9
ndc (package): 70710-1160-1
ndc (product): 70710-1159
ndc (product): 70710-1160
ndc11 (package): 70710116001
rxcui: 1300801
rxcui: 1300791
spl id: df34c0c9-8528-4fd6-a408-e1d44da0f156
spl set id: 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2
unii: MVR3JL3B2V
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675
MyrbetriqMIRABEGRONAstellas Pharma US, Inc.ba9e9e15-e666-4c56-9271-2e24739cfa2d2024-08-01Warnings, Adverse reactionsExact identifier
rxcui: 1300801
rxcui: 1300791
unii: MVR3JL3B2V
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Ferrum OxydatumFERRUM OXYDATUMHahnemann Laboratories, INC.f8b52d3f-3fe2-a850-e053-6394a90a5d9f2023-04-06Exact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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