Proventil HFA

Product NDC
50090-4326
Requested package NDC
50090-4326-0
11-digit product format
500904326
Labeler code
50090
Product ID
50090-4326_83584e7c-47f3-4ba8-a11a-ab3228cbc14c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA020503
Marketing category
NDA
Marketing start
2001-10-01
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
108 ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-432650090-4326-0IInactivated by FDA2026-08-03

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020503-001PROVENTIL-HFAALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020503-001AB1

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONBXRLD, RS1996-08-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONBXRLD, RS1996-08-153f01610625f2…
2019-09-15 20:21 UTC2019-09N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONBXRLD, RS1996-08-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONBXRLD, RS1996-08-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020503-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020503-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020503-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020503-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020503-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020503-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020503-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020503-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020503-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020503-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020503-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020503-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020503-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020503-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020503-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020503-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020503-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020503-001BX174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020503-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020503-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020503-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03N020503-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020503-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020503-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020503-001BX13f01610625f2…
2019-09-15 20:21 UTC2019-09N020503-001BX1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020503-001BX1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020503-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020503-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020503-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020503-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020503-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020503-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020503-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05N020503-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01N020503-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020503-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020503-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020503-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020503-001AB11cb3db0bc1861…

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
50090-4326-0Proventil HFA200 in 1 CANISTERAEROSOL, METERED2001
50090-4326-0Proventil HFA1 in 1 CARTONAEROSOL, METERED11
50090-4326-1Proventil HFA1 in 1 CARTONAEROSOL, METERED11
50090-4326-1Proventil HFA200 in 1 CANISTERAEROSOL, METERED2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4326PROVENTIL HFA (ALBUTEROL SULFATE) AEROSOL, METERED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 4 package rows20190614_1c16cecd-8e1d-43b2-87e9-6d79a81c26a1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.d6acb5a7-555a-463a-ae65-2911d6789b422026-01-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 020503
application number: NDA020503
Albuterol SulfateALBUTEROL SULFATESandoz Incf8a2c4b7-a162-48ab-90b0-350e4da25c662025-12-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 020503
application number: NDA020503
Albuterol SulfateALBUTEROL SULFATEREMEDYREPACK INC.32dbec5e-044a-40b6-9b88-e1396c4b4b6e2025-12-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 020503
application number: NDA020503
Albuterol SulfateALBUTEROL SULFATEProficient Rx LP07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d2023-10-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020503
application number: NDA020503

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
746763Proventil HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
746763NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Proventil]SBD1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
746763NDA020503 200 ACTUAT Proventil 0.09 MG/ACTUAT Metered Dose InhalerSY1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
746763Proventil 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 200 ACTUAT Metered Dose InhalerSY1c16cecd-8e1d-43b2-87e9-6d79a81c26a11
746763Proventil HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY1c16cecd-8e1d-43b2-87e9-6d79a81c26a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4326-0500904326001 CANISTER in 1 CARTON (50090-4326-0) > 200 AEROSOL, METERED in 1 CANISTER1 canister2019-05-300000-00-00NoNoCurrent