FDA.reportPublic FDA data

NDC 68084-952-95 - 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
68084-952
Requested NDC
68084-952-95
Package NDCs from labels
68084-952-95, 68084-952-25
Manufacturer
American Health Packaging
Effective date
2024-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Albuterol Sulfate - American Health PackagingAmerican Health Packaging2024-07-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-952-25Albuterol Sulfate30 in 1 BOX, UNIT-DOSETABLET305
68084-952-95Albuterol Sulfate1 in 1 BLISTER PACKTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-952ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]5Legacy NDC, 2 package rows20240731_b0f73459-baeb-42a7-be48-2c3647d9b205.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-952-25EA - Each68084-95210932747-c4cb-4e52-981f-44aee28ec46612015-11-12
68084-952-95EA - Each68084-95274e13657-2856-4a7c-a03d-05342393dbb112015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
albuterol sulfateACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1
albuterolACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]1
starch, cornINACTIVE INGREDIENTO8232NY3SJALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]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 7 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 197316
rxcui: 197318
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
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEMylan Pharmaceuticals Inc.23c05e9a-9df5-4978-8831-cf562aa4ba922018-12-12Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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