FDA.reportPublic FDA data

NDC 70710-1159-01 - 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
70710-1159
Requested NDC
70710-1159-01
Package NDCs from labels
70710-1159-3, 70710-1159-9, 70710-1159-1, 70710-1159-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-27
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.2026-04-27HUMAN 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
70710-1159-12024-03-04These 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
70710-1159-32024-03-04These 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
70710-1159-92024-03-04These 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
70710-1159-12024-01-30These 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
70710-1159-32024-01-30These 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
70710-1159-92024-01-30These 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
70710-1159-1Mirabegron100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
70710-1159-3Mirabegron30 in 1 BOTTLETABLET, EXTENDED RELEASE303
70710-1159-9Mirabegron90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1159MIRABEGRON 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
70710-1159-3EA - Each70710-1159a6f42771-61e8-4621-a1a1-1d60e423f50512024-05-16
70710-1159-9EA - Each70710-1159aa65f3e3-8f00-4533-8116-d5253bfd8fe912024-05-16

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 2 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Levico PrunusLEVICO PRUNUSUriel Pharmacy Inc.63db9374-8ee2-48cf-8799-454c958698082026-02-27WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Aquavit 1AQUAVIT 1Uriel Pharmacy Inc.2354fcfc-05a2-444a-ace4-b3df614131572026-02-02WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: 1K09F3G675
Large Intestine Formula 2103LARGE INTESTINE FORMULAProfessional Complementary Health Formulas532eb4c6-0f3f-4853-89e2-43168e118d652026-01-08WarningsExact identifier
unii: XM0M87F357
Geopathic Stress Drops 2096GEOPATHIC STRESS DROPSProfessional Complementary Health Formulas7d7302b8-3959-4e1e-ad1f-88d265ba9d322026-01-08WarningsExact identifier
unii: XM0M87F357
Third Chakra (Solar Plexus) 7303THIRD CHAKRA (SOLAR PLEXUS)Professional Complementary Health Formulaseea89c37-ab87-4cc7-8dfc-e7f42a580dd92026-01-08WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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