FDA.reportPublic FDA data

NDC 67184-0571-01 - 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
67184-0571
Requested NDC
67184-0571-01
Package NDCs from labels
67184-0571-1, 67184-0571-2, 67184-0571-01
Manufacturer
Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)
Effective date
2025-10-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mirabegron - Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)2025-10-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67184-0571-1Mirabegron30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
67184-0571-2Mirabegron90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

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 3 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
unii: 1K09F3G675
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
unii: 1K09F3G675
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
unii: 1K09F3G675
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
unii: 1K09F3G675
MirabegronMIRABEGRONQilu Pharmaceutical Co., Ltd.98247602-29b9-4621-8eeb-519e40b883b92025-10-21Warnings, Adverse reactionsExact identifier
application number: ANDA217989
ndc (package): 67184-0572-2
ndc (package): 67184-0571-1
ndc (package): 67184-0572-1
ndc (package): 67184-0571-2
ndc (product): 67184-0572
ndc (product): 67184-0571
ndc11 (package): 67184057101
rxcui: 1300801
rxcui: 1300791
spl id: b4283ace-4312-4cab-97c2-0722339d75b9
spl set id: 98247602-29b9-4621-8eeb-519e40b883b9
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
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
unii: 1K09F3G675
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

Reported adverse events (FAERS/openFDA)#

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