FDA.reportPublic FDA data

NDC 65302-083 - Albuterol Sulfate

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
65302-083
Package NDCs from labels
65302-083-01, 65302-083-02, 65302-083-03
Manufacturer
Holopack International
Effective date
2008-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Albuterol Sulfate - Holopack InternationalHolopack International2008-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65302-083-01Albuterol Sulfate25 in 1 POUCHSOLUTION251
65302-083-01Albuterol Sulfate3 mL in 1 VIAL, SINGLE-DOSESOLUTION31
65302-083-02Albuterol Sulfate3 mL in 1 VIAL, SINGLE-DOSESOLUTION31
65302-083-02Albuterol Sulfate30 in 1 POUCHSOLUTION301
65302-083-03Albuterol Sulfate60 in 1 POUCHSOLUTION601
65302-083-03Albuterol Sulfate3 mL in 1 VIAL, SINGLE-DOSESOLUTION31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65302-083ALBUTEROL SULFATE SOLUTION [HOLOPACK INTERNATIONAL]16 package rows20090108_f5c2fe10-c61f-4cbe-bc45-7ab14baa691c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albuterol SulfateACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [HOLOPACK INTERNATIONAL]1
AlbuterolACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [HOLOPACK INTERNATIONAL]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XALBUTEROL SULFATE SOLUTION [HOLOPACK INTERNATIONAL]1
Sulfuric AcidINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [HOLOPACK INTERNATIONAL]1

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATEChartwell RX, LLC922bf33b-4d55-4c35-9f68-72efbb17c14f2024-02-21Warnings, Adverse reactionsExact identifier
rxcui: 630208
Albuterol SulfateALBUTEROL SULFATEA-S Medication Solutions8f52f15f-3fb7-4b00-a19f-8721c5ac55db2023-07-24Warnings, Adverse reactionsExact identifier
rxcui: 630208
Albuterol SulfateALBUTEROL SULFATEMedical Purchasing Solutions, LLC6a4b4b95-d1d3-9051-e053-2a91aa0a52e82023-05-30Warnings, Adverse reactionsExact identifier
rxcui: 630208
Albuterol SulfateALBUTEROL SULFATEProficient Rx LPd3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b2022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 630208
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d2020-10-16Warnings, Adverse reactionsExact identifier
rxcui: 630208
B4EB7EFC-1100-5C8C-2609-2A465D3E5ABAf5c2fe10-c61f-4cbe-bc45-7ab14baa691c2008-12-31Warnings, Adverse reactionsExact identifier
spl id: B4EB7EFC-1100-5C8C-2609-2A465D3E5ABA
spl set id: f5c2fe10-c61f-4cbe-bc45-7ab14baa691c

Reported adverse events (FAERS/openFDA)#

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