Atrovent

Product NDC
53002-8410
Requested package NDC
53002-8410-1
11-digit product format
530028410
Labeler code
53002
Product ID
53002-8410_ae30f199-16cf-4645-8ca6-01afb7157083
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
RPK Pharmaceuticals, Inc.
Application
NDA021527
Marketing category
NDA
Marketing start
2005-05-01
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE
Active strength
17 ug/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-841053002-8410-1IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 2 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-841053002-8410-1IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-841053002-8410-1IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
N021527-001ATROVENT HFAIPRATROPIUM BROMIDE0.021MG/INHAEROSOL, METERED / INHALATIONABRLD, RS2004-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021527-001AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021527-00184744472030-01-17Drug product, Delist requested2015-05-28

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 UTC2026-02N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-273f01610625f2…
2019-09-15 20:21 UTC2019-09N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONRLD, RS2004-11-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021527-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021527-00184744472030-01-17Drug product, Delist requested2015-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021527-00184744472030-01-17Drug product, Delist requested2015-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021527-00184744472030-01-17Drug product, Delist requested2015-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021527-00184744472030-01-17Drug product2015-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021527-00184744472030-01-17Drug product2015-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021527-00184744472030-01-17Drug product2015-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021527-00184744472030-01-17Drug product2015-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021527-00184744472030-01-17Drug product2015-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021527-00184744472030-01-17Drug product2015-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021527-00184744472030-01-17Drug product2015-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021527-00184744472030-01-17Drug product2015-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021527-00184744472030-01-17Drug product2015-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021527-00184744472030-01-17Drug product2015-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021527-00184744472030-01-17Drug product2015-05-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021527-00184744472030-01-17Drug product2015-05-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021527-00184744472030-01-17Drug product2015-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021527-00184744472030-01-17Drug product2015-05-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021527-00167393332020-05-26Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021527-00169837432020-05-26Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021527-00184744472030-01-17Drug product2015-05-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021527-00184744472030-01-17Drug product2015-05-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021527-00184744472030-01-17Drug product2015-05-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021527-00184744472030-01-17Drug product2015-05-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N021527-00184744472030-01-17Drug product2015-05-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021527-00167393332020-05-26Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021527-00169837432020-05-26Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021527-00184744472030-01-17Drug product2015-05-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021527-00167393332020-05-26Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021527-00169837432020-05-26Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021527-00184744472030-01-17Drug product2015-05-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021527-00167393332020-05-26Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021527-00169837432020-05-26Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021527-00184744472030-01-17Drug product2015-05-283f01610625f2…
2019-09-15 20:21 UTC2019-09N021527-00167393332020-05-26Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021527-00169837432020-05-26Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021527-00184744472030-01-17Drug product2015-05-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N021527-00167393332020-05-26Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021527-00169837432020-05-26Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021527-00184744472030-01-17Drug product2015-05-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021527-00184744472030-01-17Drug product2015-05-286a51e52b5d6a…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atrovent HFAIPRATROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.170e98ef-5560-4068-be7d-e649068eb8842025-11-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021527
application number: NDA021527

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36cProduct name220251106
d953267a-4ca0-4d44-91ad-712cdee8ab38Product name220250630
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-8410-12025-01-30C16284748780-19d75b9cf-f125-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
53002-8410-12023-06-08C16284748780-19d75b9cf-f125-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
53002-8410-12023-01-30C16284748780-19d75b9cf-f125-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
53002-8410-12020-12-17C16284748780-19d75b9cf-f125-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
53002-8410-12020-01-31C16284748780-19d75b9cf-f125-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-8410-1AtroventHFA1 in 1 CARTONAEROSOL, METERED15
53002-8410-1AtroventHFA200 in 1 CANISTERAEROSOL, METERED2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-8410ATROVENT HFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_ae462cd6-615b-4f0d-ae6e-59007e7acab0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836368Atrovent HFA 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNae462cd6-615b-4f0d-ae6e-59007e7acab05
836343ipratropium bromide 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNae462cd6-615b-4f0d-ae6e-59007e7acab05
836368200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler [Atrovent]SBDae462cd6-615b-4f0d-ae6e-59007e7acab05
836343200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose InhalerSCDae462cd6-615b-4f0d-ae6e-59007e7acab05
836368200 ACTUAT Atrovent HFA 0.017 MG/ACTUAT Metered Dose InhalerSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836368Atrovent 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836368Atrovent HFA 17 MCG per ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836343ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836343ipratropium bromide 17 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-8410-1530028410011 CANISTER in 1 CARTON (53002-8410-1) > 200 AEROSOL, METERED in 1 CANISTER1 canister2018-10-010000-00-00NoNoCurrent