PROAIRHFA

Product NDC
52959-978
11-digit product format
529590978
Labeler code
52959
Product ID
52959-978_f3f4a975-d44b-4a91-af1a-b660b1ebb06a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
H.J. Harkins Company, Inc.
Application
NDA021457
Marketing category
NDA
Marketing start
2004-12-01
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
90 ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-978-01PROAIRHFA HFA200 in 1 INHALERAEROSOL, METERED2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-978-01GM - Gram52959-97847c14bea-7c4b-4770-8aee-a89d041ffd7512013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-978PROAIRHFA HFA (ALBUTEROL SULFATE) AEROSOL, METERED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20111118_22367ff1-5edf-429a-955a-728e42695f60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN22367ff1-5edf-429a-955a-728e42695f601
745752ProAir HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN22367ff1-5edf-429a-955a-728e42695f601
745752NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [ProAir]SBD22367ff1-5edf-429a-955a-728e42695f601
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD22367ff1-5edf-429a-955a-728e42695f601
745752200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose InhalerSY22367ff1-5edf-429a-955a-728e42695f601
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY22367ff1-5edf-429a-955a-728e42695f601
745752NDA021457 200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose InhalerSY22367ff1-5edf-429a-955a-728e42695f601
745752ProAir HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY22367ff1-5edf-429a-955a-728e42695f601
745752ProAir HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUATSY22367ff1-5edf-429a-955a-728e42695f601
745752ProAir HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY22367ff1-5edf-429a-955a-728e42695f601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-978-0152959097801200 in 1 INHALERHistorical