ProAir Digihaler

Product NDC
59310-540
11-digit product format
593100540
Labeler code
59310
Product ID
59310-540_47ecc130-3bcd-4d61-83da-4789610e042b
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
2019-10-04
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59310-540DDiscontinued by firm2026-08-03
excluded packagepackage59310-54059310-540-20DDiscontinued by firm2026-08-03
excluded packagepackage59310-54059310-540-21DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205636-001PROAIR RESPICLICKALBUTEROL SULFATEEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31
N205636-002PROAIR DIGIHALERALBUTEROL SULFATEEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31782e0a99824c…
2021-12-28 21:50 UTC2021-12N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 29 · 1,149 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-08-23 18:47 UTC2025-08N205636-001107658202025-05-19Drug product2020-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00194632882025-05-19Drug product2016-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00186511032028-03-26Drug product2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-001100225102031-05-18Drug product2018-08-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-001101241312031-05-18Drug product2018-12-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00197310872031-05-18Drug product2017-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00192162602031-06-28Drug product2016-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00189789662032-01-13Drug product2016-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002107658202025-05-19Drug product2020-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00294632882025-05-19Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00286511032028-03-26Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002100225102031-05-18Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002101241312031-05-18Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00297310872031-05-18Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00292162602031-06-28Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00289789662032-01-13Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00297825502035-08-28Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00297825512035-08-28Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002109188162035-12-14Drug product2021-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002105690342036-08-16Drug product2020-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002113513172038-02-10Drug product2022-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002113579352038-09-24Drug product2022-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002110006532038-12-18Drug product2021-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002113446852039-09-26Drug product2022-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002114397772040-05-24Drug product2022-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002114649232040-06-19Drug product2022-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002111732592040-07-06Drug product2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002112667962041-02-22Drug product2022-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-001107658202025-05-19Drug product2020-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00194632882025-05-19Drug product2016-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00186511032028-03-26Drug product2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-001100225102031-05-18Drug product2018-08-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-001101241312031-05-18Drug product2018-12-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00197310872031-05-18Drug product2017-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00192162602031-06-28Drug product2016-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-001105618082032-01-01Drug product2020-03-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00189789662032-01-13Drug product2016-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-002107658202025-05-19Drug product2020-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00294632882025-05-19Drug product2019-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00286511032028-03-26Drug product2019-01-09fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N205636-001NPP2019-04-2874a2ff9319b5…
2019-12-14 00:12 UTC2019-12N205636-001NPP2019-04-283f01610625f2…
2019-09-15 20:21 UTC2019-09N205636-001NPP2019-04-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N205636-001NPP2019-04-28ea99ee380514…

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
59310-540-20ProAir Digihaler200 in 1 INHALERPOWDER, METERED20026
59310-540-20ProAir Digihaler1 in 1 BOXPOWDER, METERED126
59310-540-21ProAir Digihaler200 in 1 INHALERPOWDER, METERED20026
59310-540-21ProAir Digihaler1 in 1 BOXPOWDER, METERED126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59310-540PROAIR DIGIHALER (ALBUTEROL SULFATE) POWDER, METERED PROAIR DIGIHALER (ALBUTEROL SULFATE) INHALANT [TEVA RESPIRATORY, LLC]26Legacy NDC, 4 package rows20240515_667ce3ec-5217-4b10-b712-f3e54fbbf087.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProAir RespiClickALBUTEROL SULFATETeva Respiratory, LLC9324e2eb-26fd-4f14-9f10-e5aa467306f42022-09-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 205636
application number: NDA205636
ProAir DigihalerALBUTEROL SULFATETeva Respiratory, LLC667ce3ec-5217-4b10-b712-f3e54fbbf0872022-06-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 205636
application number: NDA205636
ndc (product): 59310-540

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2166796albuterol 90 MCG /INHAL Dry Powder Inhaler with sensor, 200 ActuationsPSN667ce3ec-5217-4b10-b712-f3e54fbbf08726
2166797ProAir digihaler 90 MCG /INHAL Dry Powder Inhaler, 200 ActuationsPSN667ce3ec-5217-4b10-b712-f3e54fbbf08726
2166797Sensor 200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler [ProAir]SBD667ce3ec-5217-4b10-b712-f3e54fbbf08726
2166796Sensor 200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder InhalerSCD667ce3ec-5217-4b10-b712-f3e54fbbf08726
2166796albuterol 90 MCG /INHAL Dry Powder Inhaler with sensor, 200 ActuationsSY667ce3ec-5217-4b10-b712-f3e54fbbf08726
2166797ProAir digihaler 90 MCG /INHAL Dry Powder Inhaler, 200 ActuationsSY667ce3ec-5217-4b10-b712-f3e54fbbf08726
2166797Sensor 200 ACTUAT ProAir 0.09 MG/ACTUAT Dry Powder InhalerSY667ce3ec-5217-4b10-b712-f3e54fbbf08726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59310-540-20593100540201 INHALER in 1 BOX (59310-540-20) > 200 POWDER, METERED in 1 INHALER1 inhaler2019-10-040000-00-00YesNoCurrent
59310-540-2159310054021200 in 1 INHALERHistorical