FDA.reportPublic FDA data

NDC 70518-4304-00 - 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
70518-4304
Requested NDC
70518-4304-00
Package NDCs from labels
70518-4304-0, 70518-4304-00
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4304-0Mirabegron90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4304MIRABEGRON TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]2Current NDC, 1 package rows20250309_5f7a1758-8691-4e53-96d6-a01626ee8140.zip

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 1 of 1 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirabegronMIRABEGRONREMEDYREPACK INC.5f7a1758-8691-4e53-96d6-a01626ee81402026-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA209488
ndc (package): 70518-4304-0
ndc (product): 70518-4304
ndc11 (package): 70518430400
rxcui: 1300801
spl id: 5a9956d6-df8d-d72e-e063-6394a90a2126
spl set id: 5f7a1758-8691-4e53-96d6-a01626ee8140
unii: MVR3JL3B2V
MIRABEGRONMIRABEGRONREMEDYREPACK INC.d0054db9-e38a-4786-be2c-996fa5b8f47d2026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 1300801
unii: MVR3JL3B2V
MirabegronMIRABEGRONAscend Laboratories, LLC1c9022af-4841-4f3f-9737-1c5eef58e86b2026-05-22Warnings, Adverse reactionsExact identifier
unii: MVR3JL3B2V
MirabegronMIRABEGRONREMEDYREPACK INC.b71b939e-8cb1-492c-8311-28f75dc4c6822026-04-27Warnings, Adverse reactionsExact identifier
application number: ANDA209488
rxcui: 1300791
unii: MVR3JL3B2V
MirabegronMIRABEGRONAmneal Pharmaceuticals NY LLCe597023d-6dcc-4d9e-8ce0-2d28a5d862f32026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 1300801
rxcui: 1300791
unii: MVR3JL3B2V
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
MIRABEGRONMIRABEGRONLupin Pharmaceuticals, Inc.d22d3d12-8466-46db-bc19-d13e87c6115c2025-12-24Warnings, Adverse reactionsExact identifier
rxcui: 1300801
rxcui: 1300791
unii: MVR3JL3B2V
MirabegronMIRABEGRONQilu Pharmaceutical Co., Ltd.98247602-29b9-4621-8eeb-519e40b883b92025-10-21Warnings, Adverse reactionsExact identifier
rxcui: 1300801
rxcui: 1300791
unii: MVR3JL3B2V
MIRABEGRONMIRABEGRONBryant Ranch Prepack00826723-d25e-498a-b8d4-d17e5c14dda52025-09-26Warnings, Adverse reactionsExact identifier
rxcui: 1300801
unii: MVR3JL3B2V
MIRABEGRONMIRABEGRONBryant Ranch Prepack1a7337a4-2901-4e65-b666-7623fadb78f22025-09-26Warnings, Adverse reactionsExact identifier
rxcui: 1300801
unii: MVR3JL3B2V
MIRABEGRONMIRABEGRONBryant Ranch Prepack2965e083-b678-43b9-8e13-2efddc0daad02025-09-26Warnings, Adverse reactionsExact identifier
rxcui: 1300791
unii: MVR3JL3B2V
MIRABEGRONMIRABEGRONBryant Ranch Prepack3bd73250-2b31-4b22-983b-15119846e6972025-09-26Warnings, Adverse reactionsExact identifier
rxcui: 1300791
unii: MVR3JL3B2V
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 (product): 70710-1160
rxcui: 1300801
rxcui: 1300791
spl id: df34c0c9-8528-4fd6-a408-e1d44da0f156
spl set id: 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2
unii: MVR3JL3B2V
MyrbetriqMIRABEGRONAstellas Pharma US, Inc.ba9e9e15-e666-4c56-9271-2e24739cfa2d2024-08-01Warnings, Adverse reactionsExact identifier
rxcui: 1300801
rxcui: 1300791
unii: MVR3JL3B2V

Reported adverse events (FAERS/openFDA)#

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