FDA.reportPublic FDA data

NDC 50090-6796-00 - PULMICORT FLEXHALER

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
50090-6796
Requested NDC
50090-6796-00
Package NDCs from labels
50090-6796-0, 50090-6796-00
Manufacturer
A-S Medication Solutions
Effective date
2023-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PULMICORT FLEXHALER - A-S Medication SolutionsA-S Medication Solutions2023-11-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6796-0PULMICORT FLEXHALER1 in 1 CARTONAEROSOL, POWDER12
50090-6796-0PULMICORT FLEXHALER120 in 1 INHALERAEROSOL, POWDER1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6796PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20231109_10ea5d87-6ed0-4fa5-a37b-2043c8560bc0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6796-0EA - Each50090-67965ec672d7-c32f-4699-9867-10d9d7bb922812023-12-05

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 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BudesonideBUDESONIDERising Pharma Holdings, Inc.3235e2a4-8e12-2d58-e063-6294a90a49362026-07-16Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Budesonide Inhalation SuspensionBUDESONIDECipla USA Inc.c52c5382-1400-44b9-95be-a30e1cf706da2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
budesonideBUDESONIDEREMEDYREPACK INC.5e39c491-2793-410e-b77f-8b3cbe9b62312026-05-21Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDEAmerican Health Packagingc7df2a10-4166-423e-bb60-5f3a8234f26c2026-05-18Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BREZTRIBUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATEAstraZeneca Pharmaceuticals LP715433dc-cb2b-43ea-b6df-c5b4177adc6c2026-04-27Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Budesonide and Formoterol Fumarate DihydrateBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATESportpharm LLCd6cc66c9-6f97-4ea8-a787-30a048004c772026-04-24Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDECardinal Health 107, LLC3e8a6cf4-4bda-4e22-8653-12635adfb3162026-04-14Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDESun Pharmaceutical Industries, Inc.a39fbcfc-3ffd-44bd-b882-01f8e18442132026-04-14Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Budesonide InhalationBUDESONIDEPreferred Pharmaceuticals Inc.1d139a25-9c17-4b3e-8ffd-b2d562cc00ee2026-03-20Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
budesonide inhalationBUDESONIDE INHALATIONPreferred Pharmaceuticals, Inc.dd74e446-7c1b-4f02-9c73-ba716572ee772026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
SYMBICORTBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATESportpharm LLCa645756c-c692-4bc6-a858-7e7e249561bd2026-03-12Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDEAmerican Health Packaging4a8e79df-3946-4e9a-b214-e9fdd824b5652026-03-09Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDERugby Laboratories04eb9e98-1323-353f-3fd7-2d317dfac5262026-02-27WarningsExact identifier
unii: Q3OKS62Q6X
budesonideBUDESONIDEBryant Ranch Prepack33def4dc-b469-f987-e063-6294a90ace0b2026-02-17Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Budesonide InhalationBUDESONIDEAmneal Pharmaceuticals of New York LLCe8ef9489-83a2-4817-b21c-ea3fecd8c8dd2026-02-02Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
PULMICORT FLEXHALERBUDESONIDEA-S Medication Solutions5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662026-01-29Warnings, Adverse reactionsExact identifier
application number: NDA021949
rxcui: 966524
rxcui: 966522
unii: Q3OKS62Q6X
TarpeyoBUDESONIDECalliditas Therapeutics AB938cada4-d6bf-4252-836f-dd40f9eadb4d2026-01-21Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDEWalgreens9d519bf3-8d9b-5208-13c5-308edc24aca72026-01-21WarningsExact identifier
unii: Q3OKS62Q6X
BudesonideBUDESONIDECVS Pharmacyb2650d29-c011-48f1-a7f4-040011d4563d2026-01-21WarningsExact identifier
unii: Q3OKS62Q6X
B03 Sinus ReliefALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALISApex Energetics Inc.bad83f77-e9ae-7118-e053-2a95a90aa7372025-12-31WarningsExact identifier
unii: J2B2A4N98G

Reported adverse events (FAERS/openFDA)#

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