FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
76420-088
11-digit product format
764200088
Labeler code
76420
Product ID
76420-088_0cdb4881-c3c2-9edf-e063-6394a90a5cac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Asclemed USA, Inc.
Application
NDA021457
Marketing category
NDA
Marketing start
2019-01-16
Substance
ALBUTEROL SULFATE
Active strength
90 ug/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
Brand name suffix
HFA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE90 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui2123072

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
76420-088-01Albuterol SulfateHFA1 in 1 CARTONAEROSOL, METERED14
76420-088-01Albuterol SulfateHFA200 in 1 INHALERAEROSOL, METERED2004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-088-01GM - Gram76420-088c982b47c-88f3-4d01-a6ab-4b8b73aa74a612024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-088ALBUTEROL SULFATE HFA (ALBUTEROL SULFATE) AEROSOL, METERED [ASCLEMED USA, INC.]4Current NDC, Legacy NDC, 2 package rows20231220_a69489f7-4ffb-4cd1-b2d2-002f48e84f51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSNa69489f7-4ffb-4cd1-b2d2-002f48e84f514
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDa69489f7-4ffb-4cd1-b2d2-002f48e84f514
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSYa69489f7-4ffb-4cd1-b2d2-002f48e84f514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-088-01764200088011 INHALER in 1 CARTON (76420-088-01) / 200 AEROSOL, METERED in 1 INHALER1 inhaler2020-10-130000-00-00NoNoCurrent