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 6 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEAurobindo Pharma Limited370516c4-718f-4a71-bdc8-8822060ccefe2023-10-31Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEProficient Rx LP07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d2023-10-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol Sulfate HFAALBUTEROL SULFATEProficient Rx LPd617e361-5c03-45ac-9bbe-0fa418edb19f2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATEProficient Rx LP6dc143e7-6bab-42c8-b3e9-9d604d202e732023-10-01Warnings, Adverse reactionsExact identifier
application number: NDA020983
rxcui: 2123076
unii: 021SEF3731
AlbuterolALBUTEROLZydus Pharmaceuticals USA Inc.c3fa0068-fd12-45de-818e-e929fb45ba052023-08-21Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEA-S Medication Solutions8f52f15f-3fb7-4b00-a19f-8721c5ac55db2023-07-24Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEChartwell RX, LLC81cdae6f-99d7-468b-9ab8-fecb1d42298d2023-06-19Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEMedical Purchasing Solutions, LLC6a4b4b95-d1d3-9051-e053-2a91aa0a52e82023-05-30Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
albuterol sulfate HFAALBUTEROL SULFATEA-S Medication Solutions4378c5b0-529f-44b4-bdf1-e9f2631df8cd2023-02-06Warnings, Adverse reactionsExact identifier
application number: NDA020983
rxcui: 2123076
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEHikma Pharmaceuticals USA Inc.6c64ab5d-f8a2-440a-a929-cb8188d0e8b42023-01-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATEProficient Rx LP4100bce5-096c-42e4-9e4e-d11a0ab597d52023-01-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
AlbuterolALBUTEROLAurobindo Pharma Limitedff9b287b-e4a4-4c12-ad2f-6b7d55b20dc62022-12-15Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.87ff8be7-3a49-44bd-92de-eb8db24af95b2022-12-13Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstad299502-8779-d280-e053-2995a90a73712022-12-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEProficient Rx LP0b0587df-b4bd-4fae-9d79-c71362c0314b2022-12-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
albuterol sulfateALBUTEROL SULFATEProficient Rx LP918551c7-c3c1-43bc-b575-b33fdb4e96fc2022-12-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEProficient Rx LPd3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b2022-11-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
AlbuterolALBUTEROLProficient Rx LP895dff1c-d21c-4470-b021-a5b68364c1ec2022-04-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEExelan Pharmaceuticals, Inc.29e35e54-dbd6-4426-993f-893d7a4d69be2022-02-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d2020-10-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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