FDA.reportPublic FDA data

BUDESONIDE

Substance profile for UNII Q3OKS62Q6X, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Substance Identity#

UNII
Q3OKS62Q6X
Preferred term
BUDESONIDE
Registry number
51333-22-3
EC number
257-139-7
Ingredient type
INGREDIENT SUBSTANCE

Chemical And Database Identifiers#

RxCUI
19831
PubChem
0
NCIt
C1027
INN ID
4145

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
RxNorm19831mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=19831
NCI ThesaurusC1027ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C1027
FDA Substance Registration SystemQ3OKS62Q6Xprecision.fda.gov/uniisearch/srs/unii/Q3OKS62Q6X
European Community number257-139-7commonchemistry.cas.org/results?q=257-139-7

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE MOIETYThese highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1997 budesonide capsules (enteric coated) budesonide capsules (enteric coated) BUDESONIDE capsules (enteric coated), for oral use2
ACTIVE INGREDIENTThese highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1997 budesonide capsules (enteric coated) budesonide capsules (enteric coated) BUDESONIDE capsules (enteric coated), for oral use2
ACTIVE MOIETYThese highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension. BUDESONIDE inhalation suspension Initial U.S. Approval: 20001
ACTIVE INGREDIENTThese highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension. BUDESONIDE inhalation suspension Initial U.S. Approval: 20001
ACTIVE INGREDIENTThese 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: 20062
ACTIVE MOIETYThese 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: 20062
ACTIVE INGREDIENTThese highlights do not include all the information needed to use PULMICORT RESPULES ® safely and effectively. See full prescribing information for PULMICORT RESPULES ® . PULMICORT RESPULES ® (BUDESONIDE INHALATION SUSPENSION) INITIAL U.S. APPROVAL 20002
ACTIVE MOIETYThese highlights do not include all the information needed to use PULMICORT RESPULES ® safely and effectively. See full prescribing information for PULMICORT RESPULES ® . PULMICORT RESPULES ® (BUDESONIDE INHALATION SUSPENSION) INITIAL U.S. APPROVAL 20002
ACTIVE MOIETYThese highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension. BUDESONIDE inhalation suspension Initial U.S. Approval: 20002
ACTIVE INGREDIENTThese highlights do not include all the information needed to use budesonide inhalation suspension safely and effectively. See full prescribing information for budesonide inhalation suspension. BUDESONIDE inhalation suspension Initial U.S. Approval: 20002
ACTIVE INGREDIENTThese highlights do not include all the information needed to use RHINOCORT AQUA ® Nasal Spray safely and effectively. See full prescribing information for RHINOCORT AQUA Nasal Spray. RHINOCORT AQUA 32 mcg (budesonide) Nasal Spray. INITIAL U.S. APPROVAL: 19993
ACTIVE MOIETYThese highlights do not include all the information needed to use RHINOCORT AQUA ® Nasal Spray safely and effectively. See full prescribing information for RHINOCORT AQUA Nasal Spray. RHINOCORT AQUA 32 mcg (budesonide) Nasal Spray. INITIAL U.S. APPROVAL: 19993
ACTIVE MOIETYENTOCORT® EC (budesonide) CAPSULES2
ACTIVE INGREDIENTENTOCORT® EC (budesonide) CAPSULES2
ACTIVE INGREDIENTThese 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: 20061
ACTIVE MOIETYThese 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: 20061
ACTIVE INGREDIENTENTOCORT® EC (budesonide) CAPSULES6
ACTIVE MOIETYENTOCORT® EC (budesonide) CAPSULES6
ACTIVE INGREDIENTPULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [ASTRAZENECA LP]14
ACTIVE MOIETYPULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [ASTRAZENECA LP]14
ACTIVE MOIETYPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
ACTIVE INGREDIENTPULMICORT RESPULES (BUDESONIDE) SUSPENSION [ASTRAZENECA LP]14
ACTIVE MOIETYSYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]14
ACTIVE INGREDIENTSYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ASTRAZENECA LP]14
ACTIVE MOIETYRHINOCORT AQUA (BUDESONIDE) SPRAY, METERED [ASTRAZENECA LP]13
ACTIVE INGREDIENTRHINOCORT AQUA (BUDESONIDE) SPRAY, METERED [ASTRAZENECA LP]13
ACTIVE INGREDIENTUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
ACTIVE MOIETYUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
ACTIVE INGREDIENTBUDESONIDE INHALATION (BUDESONIDE) SUSPENSION [WATSON LABORATORIES, INC.]8
ACTIVE MOIETYBUDESONIDE INHALATION (BUDESONIDE) SUSPENSION [WATSON LABORATORIES, INC.]8
ACTIVE INGREDIENTBUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC]8
ACTIVE MOIETYBUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA INC]8
ACTIVE INGREDIENTBUDESONIDE CAPSULE [PAR PHARMACEUTICAL INC.]7
ACTIVE MOIETYBUDESONIDE CAPSULE [PAR PHARMACEUTICAL INC.]7
ACTIVE MOIETYBUDESONIDE SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]6
ACTIVE INGREDIENTBUDESONIDE SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]6
ACTIVE MOIETYBUDESONIDE SUSPENSION [CARDINAL HEALTH]5
ACTIVE INGREDIENTBUDESONIDE SUSPENSION [CARDINAL HEALTH]5
ACTIVE MOIETYENTOCORT EC (BUDESONIDE) CAPSULE [ASTRAZENECA LP]5
ACTIVE INGREDIENTENTOCORT EC (BUDESONIDE) CAPSULE [ASTRAZENECA LP]5
ACTIVE INGREDIENTT.R.U.E. TEST THIN-LAYER RAPID USE PATCH TEST (STANDARDIZED ALLERGENIC) KIT [SMARTPRACTICE DENMARK APS]5
ACTIVE MOIETYT.R.U.E. TEST THIN-LAYER RAPID USE PATCH TEST (STANDARDIZED ALLERGENIC) KIT [SMARTPRACTICE DENMARK APS]5
ACTIVE MOIETYBUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
ACTIVE INGREDIENTBUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]3
ACTIVE MOIETYBUDESONIDE INHALATION (BUDESONIDE) SUSPENSION [PREFERRED PHARMACEUTICALS INC.]3
ACTIVE INGREDIENTBUDESONIDE INHALATION (BUDESONIDE) SUSPENSION [PREFERRED PHARMACEUTICALS INC.]3
ACTIVE INGREDIENTBUDESONIDE NASAL (BUDESONIDE) SPRAY, METERED [APOTEX CORP.]3
ACTIVE MOIETYBUDESONIDE NASAL (BUDESONIDE) SPRAY, METERED [APOTEX CORP.]3
ACTIVE INGREDIENTBUDESONIDE SPRAY, METERED [PAR PHARMACEUTICAL INC.]3
ACTIVE MOIETYBUDESONIDE SPRAY, METERED [PAR PHARMACEUTICAL INC.]3
ACTIVE MOIETYPULMICORT RESPULES (BUDESONIDE) SUSPENSION [CARDINAL HEALTH]3
ACTIVE INGREDIENTPULMICORT RESPULES (BUDESONIDE) SUSPENSION [CARDINAL HEALTH]3
ACTIVE INGREDIENTBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
ACTIVE MOIETYBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
ACTIVE INGREDIENTBUDESONIDE SUSPENSION [APOTEX CORP.]2
ACTIVE MOIETYBUDESONIDE SUSPENSION [APOTEX CORP.]2
ACTIVE MOIETYPULMICORT TURBUHALER (BUDESONIDE) POWDER, METERED [ASTRAZENECA LP]2
ACTIVE INGREDIENTPULMICORT TURBUHALER (BUDESONIDE) POWDER, METERED [ASTRAZENECA LP]2
ACTIVE MOIETYBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ACTIVE INGREDIENTBUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ACTIVE INGREDIENTBUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]1
ACTIVE MOIETYBUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]1
ACTIVE MOIETYBUDESONIDE SPRAY, METERED [ASTRAZENECA LP]1
ACTIVE INGREDIENTBUDESONIDE SPRAY, METERED [ASTRAZENECA LP]1
ACTIVE MOIETYBUDESONIDE SUSPENSION [SANDOZ INC]1
ACTIVE INGREDIENTBUDESONIDE SUSPENSION [SANDOZ INC]1