Atrovent

Product NDC
50090-0961
Requested package NDC
50090-0961-0
11-digit product format
500900961
Labeler code
50090
Product ID
50090-0961_1e4ea42f-ed4a-43d6-9219-31d5d9e2934f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
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
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 packagepackage50090-096150090-0961-0IInactivated by FDA2026-10-05

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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONABRLD, RS2004-11-2784e616aacf4f…
2026-08-18 06:07:402026-07N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONABRLD, RS2004-11-27caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021527-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N021527-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021527-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 55 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N021527-00184744472030-01-17Drug product, Delist requested2015-05-2884e616aacf4f…
2026-08-18 06:07:402026-07N021527-00184744472030-01-17Drug product, Delist requested2015-05-28caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0961-0AtroventHFA200 in 1 CANISTERAEROSOL, METERED20011
50090-0961-0AtroventHFA1 in 1 CARTONAEROSOL, METERED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0961-0GM - Gram50090-0961fae3891c-3003-4aa1-b32d-daaa2ae5762f12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0961ATROVENT HFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [A-S MEDICATION SOLUTIONS]11Legacy NDC, 2 package rows20190225_70c16bb6-fdf8-45bf-8f01-8e33889d17ac.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 · 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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836368Atrovent HFA 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836343ipratropium bromide 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836368200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler [Atrovent]SBD70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836343200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose InhalerSCD70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836368200 ACTUAT Atrovent HFA 0.017 MG/ACTUAT Metered Dose InhalerSY70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836368Atrovent 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836368Atrovent HFA 17 MCG per ACTUAT Metered Dose Inhaler, 200 ACTUATSY70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836343ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836343ipratropium bromide 17 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY70c16bb6-fdf8-45bf-8f01-8e33889d17ac11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0961-0500900961001 CANISTER in 1 CARTON (50090-0961-0) > 200 AEROSOL, METERED in 1 CANISTER1 canister2014-11-280000-00-00NoNoCurrent