FDA.reportPublic FDA data

NDC 80425-0359-01 - Albuterol Sulfate HFA

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
80425-0359
Requested NDC
80425-0359-01
Package NDCs from labels
80425-0359-1, 80425-0359-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Albuterol Sulfate HFA - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0359-1Albuterol SulfateHFA1 in 1 CARTONAEROSOL, METERED12
80425-0359-1Albuterol SulfateHFA200 in 1 INHALERAEROSOL, METERED2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0359ALBUTEROL SULFATE HFA (ALBUTEROL SULFATE) AEROSOL, METERED [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 2 package rows20250101_04c8a345-0a0d-5a01-e063-6294a90a40d2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0359-1GM - Gram80425-0359a76bc2c0-0465-41b1-9f5e-18794a9131a412023-10-16

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 3 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlbuterolALBUTEROL SULFATECipla USA Inc.fd0389e0-3713-42e0-8ef2-3bb97676fded2026-01-04Warnings, Adverse reactionsExact identifier
rxcui: 2123076
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEChartwell Governmental & Specialty RX, LLC.dd47559a-84f6-42a5-a00e-48754505418e2025-12-17Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATESandoz Incf8a2c4b7-a162-48ab-90b0-350e4da25c662025-12-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIPRATROPIUM BROMIDE AND ALBUTEROL SULFATERitedose Pharmaceuticals, LLCe0dee492-8bf9-4360-be9b-9d6ee1ecb2562025-12-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEChartwell RX, LLCb444478a-10ce-484f-9039-6383dfb8161e2025-12-02Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Combivent RespimatIPRATROPIUM BROMIDE AND ALBUTEROLBoehringer Ingelheim Pharmaceuticals, Inc.9832312e-0310-4ab6-8501-afa976fc7eb22025-12-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEBryant Ranch Prepack378461f2-7271-44a3-9da3-b39970b65d3a2025-11-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENephron Pharmaceuticals Corporation574824f3-51cc-4b94-9c10-e3204d8b19f82025-11-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEASCLEMED USA INC.8ea40065-4f59-434f-9ea1-7ef006fde66e2025-11-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.056e145b-87aa-4009-a7ab-2ac0bd086eb02025-11-06Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals, Inc.2c3f975c-dbd8-0362-e063-6394a90a16dd2025-10-21Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.4120061a-dbae-8918-e063-6394a90afbf22025-10-14Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals, Inc.081b7bbb-6692-4512-b135-863b73bf30a52025-10-13Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
AIRSUPRAALBUTEROL SULFATE AND BUDESONIDEAstraZeneca Pharmaceuticals LPe60aa9f9-5139-44df-b886-ebddc3c7eb132025-09-18Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol Sulate HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.825975b1-a4a9-78ca-e053-2a91aa0a39482025-09-02Warnings, Adverse reactionsExact identifier
application number: NDA020983
rxcui: 2123076
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEQUAGEN PHARMACEUTICALS LLC99a490cc-e41d-436b-9cf3-8facb7ac714f2025-07-03Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATEPreferred Pharmaceuticals, Inc.99782bc8-56d9-41f8-935e-0d0de27f0c342025-05-19Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.1c72fd84-7dbc-45d0-ab88-fb4221ce369f2025-05-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATEAsclemed USA, Inc.264e2145-c7d4-4f4f-aa5b-9fe48a7c5b472025-05-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
AlbuterolALBUTEROLBryant Ranch Prepack601a18ed-d66e-498f-a804-f1a3330827d42025-04-21Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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