FDA.reportPublic FDA data

NDC 50090-4508-00 - SYMBICORT

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
50090-4508
Requested NDC
50090-4508-00
Package NDCs from labels
50090-4508-0, 50090-4508-00
Manufacturer
A-S Medication Solutions
Effective date
2024-04-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SYMBICORT - A-S Medication SolutionsA-S Medication Solutions2024-04-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4508-0SYMBICORT1 in 1 POUCHAEROSOL111
50090-4508-0SYMBICORT1 in 1 CARTONAEROSOL111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4508SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [A-S MEDICATION SOLUTIONS]11Current NDC, 2 package rows20240418_5feb8f35-b237-477a-9836-2a6db2ed6fa7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4508-0GM - Gram50090-45082dec2090-0c5f-44c6-94bb-191324b5571f12024-05-16

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 · 88 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
DuleraMOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATEOrganon LLC8f399784-f257-4f31-b3dc-368bf2a1864d2026-07-10Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
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
TrimbowBECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATEChiesi USA, Inc.4e13e70f-f550-4603-bbfb-346f80df3c4f2026-05-20Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
BudesonideBUDESONIDEAmerican Health Packagingc7df2a10-4166-423e-bb60-5f3a8234f26c2026-05-18Warnings, Adverse reactionsExact identifier
unii: Q3OKS62Q6X
Formoterol fumarateFORMOTEROL FUMARATE DIHYDRATENorthStar RxLLC4dbb9620-5731-40d9-8258-2977ecc781c42026-05-01Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
Formoterol fumarateFORMOTEROL FUMARATE DIHYDRATELifestar Pharma LLC35538d89-a984-4335-acdf-85a893f51eee2026-05-01Warnings, Adverse reactionsExact identifier
unii: W34SHF8J2K
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
application number: NDA021929
rxcui: 1246304
rxcui: 1246288
unii: Q3OKS62Q6X
unii: W34SHF8J2K
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
application number: NDA021929
rxcui: 1246314
rxcui: 1246315
unii: Q3OKS62Q6X
unii: W34SHF8J2K
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
unii: Q3OKS62Q6X

Reported adverse events (FAERS/openFDA)#

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