FDA.reportPublic FDA data

budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT

RxCUI
966527
RxNorm name
budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT
Display name
budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT
Full name
budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

RxNav Current And Historical NDCs#

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UNII Substances#

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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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PULMICORT FLEXHALERBUDESONIDERubicon Holdings Inc.ae1105cd-69fc-4c15-937f-c535304341c22025-09-04Warnings, Adverse reactionsExact identifier
rxcui: 966527
PULMICORT FLEXHALERBUDESONIDEH2-Pharma LLC10f2ae5b-a6fb-4804-9111-0cd067c2b1b22025-01-15Warnings, Adverse reactionsExact identifier
rxcui: 966527

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
10f2ae5b-a6fb-4804-9111-0cd067c2b1b2budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUATSY28These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER . PULMICORT FLEXHALER™ (budesonide) inhalation powder Initial U.S. Approval: 200620250115
10f2ae5b-a6fb-4804-9111-0cd067c2b1b2budesonide 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY28These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER . PULMICORT FLEXHALER™ (budesonide) inhalation powder Initial U.S. Approval: 200620250115
10f2ae5b-a6fb-4804-9111-0cd067c2b1b260 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder InhalerSCD28These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER . PULMICORT FLEXHALER™ (budesonide) inhalation powder Initial U.S. Approval: 200620250115
10f2ae5b-a6fb-4804-9111-0cd067c2b1b2budesonide 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUATPSN28These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER . PULMICORT FLEXHALER™ (budesonide) inhalation powder Initial U.S. Approval: 200620250115
ae1105cd-69fc-4c15-937f-c535304341c260 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder InhalerSCD2These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER . PULMICORT FLEXHALER™ (budesonide) inhalation powder Initial U.S. Approval: 200620250701
ae1105cd-69fc-4c15-937f-c535304341c2budesonide 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUATPSN2These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER . PULMICORT FLEXHALER™ (budesonide) inhalation powder Initial U.S. Approval: 200620250701
ae1105cd-69fc-4c15-937f-c535304341c2budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUATSY2These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER . PULMICORT FLEXHALER™ (budesonide) inhalation powder Initial U.S. Approval: 200620250701
ae1105cd-69fc-4c15-937f-c535304341c2budesonide 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY2These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER . PULMICORT FLEXHALER™ (budesonide) inhalation powder Initial U.S. Approval: 200620250701
0950cd08-a48b-4376-9647-da22cf5a8a70budesonide 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUATPSN1These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER™. PULMICORT FLEXHALER™ 90 MCG, 180 MCG (BUDESONIDE INHALATION POWDER) Initial U.S. Approval: 200620110906
0950cd08-a48b-4376-9647-da22cf5a8a7060 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder InhalerSCD1These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER™. PULMICORT FLEXHALER™ 90 MCG, 180 MCG (BUDESONIDE INHALATION POWDER) Initial U.S. Approval: 200620110906
0950cd08-a48b-4376-9647-da22cf5a8a70budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUATSY1These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER™. PULMICORT FLEXHALER™ 90 MCG, 180 MCG (BUDESONIDE INHALATION POWDER) Initial U.S. Approval: 200620110906
0950cd08-a48b-4376-9647-da22cf5a8a70budesonide 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY1These highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER™. PULMICORT FLEXHALER™ 90 MCG, 180 MCG (BUDESONIDE INHALATION POWDER) Initial U.S. Approval: 200620110906