ProAir RespiClick

Product NDC
59310-580
11-digit product format
593100580
Labeler code
59310
Product ID
59310-580_4d670f5c-7719-4e68-8a96-dcd26421d29c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Teva Respiratory, LLC
Application
NDA205636
Marketing category
NDA
Marketing start
2015-04-23
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
ProAir RespiClick
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE90 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui1649560, 1649961

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
59310-580-20ProAir RespiClick1 in 1 BOXPOWDER, METERED111
59310-580-20ProAir RespiClick200 in 1 INHALERPOWDER, METERED20011
59310-580-21ProAir RespiClick1 in 1 BOXPOWDER, METERED111
59310-580-21ProAir RespiClick200 in 1 INHALERPOWDER, METERED20011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59310-580PROAIR RESPICLICK (ALBUTEROL SULFATE) POWDER, METERED [TEVA RESPIRATORY, LLC]11Current NDC, Legacy NDC, 4 package rows20240207_9324e2eb-26fd-4f14-9f10-e5aa467306f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649560albuterol sulfate 90 MCG/INHAL Dry Powder Inhaler, 200 ActuationsPSN9324e2eb-26fd-4f14-9f10-e5aa467306f411
1649961ProAir RespiClick 90 MCG/INHAL Dry Powder Inhaler, 200 ActuationsPSN9324e2eb-26fd-4f14-9f10-e5aa467306f411
1649961200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler [ProAir]SBD9324e2eb-26fd-4f14-9f10-e5aa467306f411
1649560200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder InhalerSCD9324e2eb-26fd-4f14-9f10-e5aa467306f411
1649961200 ACTUAT ProAir 0.09 MG/ACTUAT Dry Powder InhalerSY9324e2eb-26fd-4f14-9f10-e5aa467306f411
1649560albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 200 ACTUAT Dry Powder InhalerSY9324e2eb-26fd-4f14-9f10-e5aa467306f411
1649560albuterol 90 MCG/ACTUAT Dry Powder Inhaler, 200 ACTUATSY9324e2eb-26fd-4f14-9f10-e5aa467306f411
1649961ProAir RespiClick 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) Dry Powder Inhaler, 200 ACTUATSY9324e2eb-26fd-4f14-9f10-e5aa467306f411
1649961ProAir RespiClick 90 MCG/ACTUAT Dry Powder Inhaler, 200 ACTUATSY9324e2eb-26fd-4f14-9f10-e5aa467306f411
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
59310-580-20593100580201 INHALER in 1 BOX (59310-580-20) / 200 POWDER, METERED in 1 INHALER1 inhaler2015-05-110000-00-00NoNoCurrent
59310-580-21593100580211 INHALER in 1 BOX (59310-580-21) > 200 POWDER, METERED in 1 INHALER1 inhaler2015-04-230000-00-00NoNoCurrent