FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
68084-949
11-digit product format
680840949
Labeler code
68084
Product ID
68084-949_1e7d3421-f562-17f5-e063-6294a90a9358
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA072637
Marketing category
ANDA
Marketing start
2015-09-22
Substance
ALBUTEROL SULFATE
Active strength
2 mg/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui197316, 197318

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-949-25Albuterol Sulfate30 in 1 BOX, UNIT-DOSETABLET305
68084-949-95Albuterol Sulfate1 in 1 BLISTER PACKTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-949-25EA - Each68084-949eca9a593-f617-4c87-8c9a-50d7a6b4dca312015-10-02
68084-949-95EA - Each68084-949b222496d-8c4d-4f4a-85c2-3bd2037c5fb012015-10-02

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-949ALBUTEROL SULFATE TABLET [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20240731_b0f73459-baeb-42a7-be48-2c3647d9b205.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197316albuterol 2 MG Oral TabletPSNb0f73459-baeb-42a7-be48-2c3647d9b2055
197318albuterol 4 MG Oral TabletPSNb0f73459-baeb-42a7-be48-2c3647d9b2055
197316albuterol 2 MG Oral TabletSCDb0f73459-baeb-42a7-be48-2c3647d9b2055
197318albuterol 4 MG Oral TabletSCDb0f73459-baeb-42a7-be48-2c3647d9b2055
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSYb0f73459-baeb-42a7-be48-2c3647d9b2055
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSYb0f73459-baeb-42a7-be48-2c3647d9b2055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-949-256808409492530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-949-25) / 1 TABLET in 1 BLISTER PACK (68084-949-95) 30 blister pack2015-09-220000-00-00NoNoCurrent
68084-949-95680840949951 in 1 BLISTER PACKHistorical