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 5 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Albuterol SulfateALBUTEROL SULFATEAmerican Health Packagingb0f73459-baeb-42a7-be48-2c3647d9b2052024-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA072637
ndc (package): 68084-949-95
ndc (package): 68084-949-25
ndc (package): 68084-952-95
ndc (package): 68084-952-25
ndc (product): 68084-949
ndc (product): 68084-952
ndc11 (package): 68084095295
rxcui: 197316
rxcui: 197318
spl id: 1e7d3421-f562-17f5-e063-6294a90a9358
spl set id: b0f73459-baeb-42a7-be48-2c3647d9b205
unii: 021SEF3731
Albuterol sulfateALBUTEROL SULFATENuCare Pharmaceuticals,Inc.b478d9e9-9704-6af2-e053-2995a90aafd42024-07-17Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.7043bc12-8a58-8ff8-e053-2a91aa0ab6272024-07-16Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.54d90668-5237-4330-e054-00144ff88e882024-07-15Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol Sulfate HFAALBUTEROL SULFATENuCare Pharmaceuticals,Inc.8c278b6f-d32b-b750-e053-2995a90ad7e92024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEA-S Medication Solutionse452afc2-dc33-4be7-949e-143b2e5f530c2024-06-10Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEAmerican Health Packagingc04c6ec8-1401-424d-8126-63080e36c4b92024-06-03Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATEA-S Medication Solutionsaa6d5c00-46a5-4f93-95e4-09319abfe71e2024-05-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEA-S Medication Solutions19867b61-77a2-46f1-97c7-7fadfec5882b2024-05-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATEA-S Medication Solutionsaff836e4-34f2-4ab9-bbf8-0c41ac848cb02024-05-07Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol Sulfate HFAALBUTEROL SULFATEPrasco Laboratoriesb25d9d6b-eb4c-452e-89ef-10e611deebd62024-04-30Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
VENTOLIN HFAALBUTEROL SULFATEGlaxoSmithKline LLCd92c5d6b-ff10-4087-36a2-1cfc464cb9672024-04-26Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirst767a1504-1e04-1e06-e053-2a91aa0aa4b62024-02-22Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEChartwell RX, LLC.7f261a9b-65d9-408a-8609-c1b3809b8b4b2024-02-21Warnings, Adverse reactionsExact identifier
unii: 021SEF3731
Albuterol SulfateALBUTEROL SULFATEChartwell RX, LLC4e48ccbe-3ec0-4bf2-be28-83eb9baa63d62024-02-21Warnings, Adverse reactionsExact identifier
unii: 021SEF3731

Reported adverse events (FAERS/openFDA)#

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