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 4 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATENephron Pharmaceuticals Corporationae35ec1f-526a-49bf-8262-c50e40190d1f2025-04-08Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEProficient Rx LPa6545fbe-b0a6-41ae-8bb6-91af38410f562025-04-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEChartwell RX, LLC560df50c-e2c4-459f-9d89-bf7e6588949e2025-03-28Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENephron Pharmaceuticals Corporationecc00500-58b8-491f-80df-dc6c89a08cae2025-03-21Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
AlbuterolALBUTEROLRising Pharma Holdings, Inc.40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c2025-03-06Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.813d49be-3651-6759-e053-2991aa0a6a9f2025-02-06Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATELupin Pharmaceuticals, Inc.973b8686-c6ce-4280-85c4-c1e7ceab3c092025-01-23Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.749992b4-69e0-0cc8-e053-2991aa0aeb252025-01-08Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirst9d4ef83f-8ca0-811e-e053-2995a90a6d0d2025-01-08Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEPreferred Pharmaceuticals, Inc.4aafc2dd-744d-4726-828f-70355aee6f702025-01-03Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEProficient Rx LP53eecdef-a7ff-4ca3-a313-d4b9c29c898d2025-01-01Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol Sulfate HFAALBUTEROL SULFATEAdvanced Rx of Tennessee, LLC04c8a345-0a0d-5a01-e063-6294a90a40d22024-12-31Warnings, Adverse reactionsExact identifier
application number: NDA020983
ndc (package): 80425-0359-1
ndc (product): 80425-0359
ndc11 (package): 80425035901
rxcui: 2123076
spl id: 2a996b2b-b5da-65e7-e063-6394a90adeed
spl set id: 04c8a345-0a0d-5a01-e063-6294a90a40d2
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEAdvanced Rx Pharmacy of Tennessee, LLCf44b325d-0f74-552c-e053-2995a90ac1c92024-12-31Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol Sulfate InhalationALBUTEROL SULFATEAmneal Pharmaceuticals NY LLC2e449282-ee58-4e36-b983-85c4e6f0864d2024-12-20Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
AlbuterolALBUTEROLZydus Lifesciences Limiteda4709eea-e4a2-46e2-850f-1e6afca018932024-11-25Exact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEIngenus Pharmaceuticals, LLCe14f5fd6-d01a-489d-9baa-61778b1352a82024-10-22Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
albuterol sulfateALBUTEROL SULFATEPadagis Israel Pharmaceuticals Ltd489201d2-9ed0-419b-81dc-a7f7f86b59ed2024-09-30Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEBryant Ranch Prepack45e07bdd-78f9-4055-9de3-646e67de7eaf2024-08-15Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATELuoxin Aurovitas Pharma (Chengdu) Co., Ltd.1d6be2b8-c670-b783-e063-6294a90ae5032024-07-31Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma Limited78e6bee2-7113-46cf-8c97-dc61b0f7b94f2024-07-31Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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