FDA.reportPublic FDA data

PROAIR

Product NDC
64725-5790
11-digit product format
647255790
Labeler code
64725
Product ID
64725-5790_b6f855b9-e909-4163-b6c9-892239ae2a07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
TYA Pharmaceuticals
Application
NDA021457
Marketing category
NDA
Marketing start
2012-12-03
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-5790-12020-01-31C16284748780-19d75b9d0-6526-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PROAIR HFA safely and effectively. See full prescribing information for PROAIR HFA Inhalation Aerosol PROAIR HFA (albuterol sulfate) INHALATION AEROSOL Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-5790-1PROAIR HFA200 in 1 INHALERAEROSOL, METERED2002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731PROAIR HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TYA PHARMACEUTICALS]2
ALBUTEROLACTIVE MOIETYQF8SVZ843EPROAIR HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TYA PHARMACEUTICALS]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROAIR HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TYA PHARMACEUTICALS]2
NORFLURANEINACTIVE INGREDIENTDH9E53K1Y8PROAIR HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-5790PROAIR HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141110_374cbcbb-a37c-4057-b9a9-f70b3fdb803c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN374cbcbb-a37c-4057-b9a9-f70b3fdb803c2
745752ProAir HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN374cbcbb-a37c-4057-b9a9-f70b3fdb803c2
745752NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [ProAir]SBD374cbcbb-a37c-4057-b9a9-f70b3fdb803c2
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD374cbcbb-a37c-4057-b9a9-f70b3fdb803c2
745752200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose InhalerSY374cbcbb-a37c-4057-b9a9-f70b3fdb803c2
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY374cbcbb-a37c-4057-b9a9-f70b3fdb803c2
745752NDA021457 200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose InhalerSY374cbcbb-a37c-4057-b9a9-f70b3fdb803c2
745752ProAir HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY374cbcbb-a37c-4057-b9a9-f70b3fdb803c2
745752ProAir HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUATSY374cbcbb-a37c-4057-b9a9-f70b3fdb803c2
745752ProAir HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY374cbcbb-a37c-4057-b9a9-f70b3fdb803c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-5790-164725579001200 in 1 INHALERHistorical