FDA.reportPublic FDA data

NDC 70518-4631-01 - 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
70518-4631
Requested NDC
70518-4631-01
Package NDCs from labels
70518-4631-1, 70518-4631-0, 70518-4631-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4631-0Mirabegron50 in 1 BOXTABLET, EXTENDED RELEASE501
70518-4631-1Mirabegron1 in 1 POUCHTABLET, EXTENDED RELEASE11

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 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MirabegronMIRABEGRONREMEDYREPACK INC.5f7a1758-8691-4e53-96d6-a01626ee81402026-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA209488
rxcui: 1300801
unii: MVR3JL3B2V
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
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
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MirabegronMIRABEGRONREMEDYREPACK INC.b71b939e-8cb1-492c-8311-28f75dc4c6822026-04-27Warnings, Adverse reactionsExact identifier
application number: ANDA209488
ndc (package): 70518-4631-0
ndc (package): 70518-4631-1
ndc (product): 70518-4631
ndc11 (package): 70518463101
rxcui: 1300791
spl id: 5076a7de-d811-a873-e063-6294a90a5c37
spl set id: b71b939e-8cb1-492c-8311-28f75dc4c682
unii: MVR3JL3B2V
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675
MirabegronMIRABEGRONAmneal Pharmaceuticals NY LLCe597023d-6dcc-4d9e-8ce0-2d28a5d862f32026-03-26Warnings, 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.