FDA.reportPublic FDA data

ProAir RespiClick

Product NDC
53002-1750
11-digit product format
530021750
Labeler code
53002
Product ID
53002-1750_740a54b2-fc44-48b5-87ba-3073f6a1cf9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
RPK Pharmaceuticals, Inc.
Application
NDA205636
Marketing category
NDA
Marketing start
2015-04-23
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
No
Listing certified through
2021-12-31
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
53002-1750-12025-01-30C16284748780-19d75b9d0-e89f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR® RESPICLICK® (albuterol sulfate) inhalation powder, for oral inhalation use Initial U.S. Approval: 1981
53002-1750-12023-06-07C16284748780-19d75b9d0-e89f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR® RESPICLICK® (albuterol sulfate) inhalation powder, for oral inhalation use Initial U.S. Approval: 1981
53002-1750-12023-01-30C16284748780-19d75b9d0-e89f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR® RESPICLICK® (albuterol sulfate) inhalation powder, for oral inhalation use Initial U.S. Approval: 1981
53002-1750-12020-12-15C16284748780-19d75b9d0-e89f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR® RESPICLICK® (albuterol sulfate) inhalation powder, for oral inhalation use Initial U.S. Approval: 1981
53002-1750-12020-01-31C16284748780-19d75b9d0-e89f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR® RESPICLICK® (albuterol sulfate) inhalation powder, for oral inhalation use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1750-1ProAir RespiClick1 in 1 BOXPOWDER, METERED15
53002-1750-1ProAir RespiClick200 in 1 INHALERPOWDER, METERED2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1750PROAIR RESPICLICK (ALBUTEROL SULFATE) POWDER, METERED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_28e6becd-a65a-4245-b282-5766127567a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649560albuterol sulfate 90 MCG/INHAL Dry Powder Inhaler, 200 ActuationsPSN28e6becd-a65a-4245-b282-5766127567a25
1649961ProAir RespiClick 90 MCG/INHAL Dry Powder Inhaler, 200 ActuationsPSN28e6becd-a65a-4245-b282-5766127567a25
1649961200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler [ProAir]SBD28e6becd-a65a-4245-b282-5766127567a25
1649560200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder InhalerSCD28e6becd-a65a-4245-b282-5766127567a25
1649961200 ACTUAT ProAir 0.09 MG/ACTUAT Dry Powder InhalerSY28e6becd-a65a-4245-b282-5766127567a25
1649560albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 200 ACTUAT Dry Powder InhalerSY28e6becd-a65a-4245-b282-5766127567a25
1649560albuterol 90 MCG/ACTUAT Dry Powder Inhaler, 200 ACTUATSY28e6becd-a65a-4245-b282-5766127567a25
1649961ProAir RespiClick 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) Dry Powder Inhaler, 200 ACTUATSY28e6becd-a65a-4245-b282-5766127567a25
1649961ProAir RespiClick 90 MCG/ACTUAT Dry Powder Inhaler, 200 ACTUATSY28e6becd-a65a-4245-b282-5766127567a25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1750-1530021750011 INHALER in 1 BOX (53002-1750-1) > 200 POWDER, METERED in 1 INHALER1 inhaler2018-10-010000-00-00NoNoCurrent