Home NDC 50090-0961-0 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
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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021527-001 ATROVENT HFA IPRATROPIUM BROMIDE 0.021MG/INH AEROSOL, METERED / INHALATION AB RLD, RS 2004-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021527-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021527-001 8474447 2030-01-17 Drug product, Delist requested 2015-05-28
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION AB RLD, RS 2004-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION AB RLD, RS 2004-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021527-001 ATROVENT HFA 0.021MG/INH AEROSOL, METERED / INHALATION RLD, RS 2004-11-27 f41ea6bd6efb…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 N021527-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021527-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021527-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 55 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021527-001 8474447 2030-01-17 Drug product, Delist requested 2015-05-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021527-001 8474447 2030-01-17 Drug product, Delist requested 2015-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021527-001 8474447 2030-01-17 Drug product, Delist requested 2015-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021527-001 8474447 2030-01-17 Drug product, Delist requested 2015-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021527-001 8474447 2030-01-17 Drug product, Delist requested 2015-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021527-001 6739333 2020-05-26 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021527-001 6983743 2020-05-26 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021527-001 6739333 2020-05-26 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021527-001 6983743 2020-05-26 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021527-001 6739333 2020-05-26 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021527-001 6983743 2020-05-26 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021527-001 6739333 2020-05-26 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021527-001 6983743 2020-05-26 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021527-001 6739333 2020-05-26 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021527-001 6983743 2020-05-26 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021527-001 8474447 2030-01-17 Drug product 2015-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021527-001 6739333 2020-05-26 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021527-001 6983743 2020-05-26 Drug product ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-0961-0 AtroventHFA 200 in 1 CANISTER AEROSOL, METERED 200 11 50090-0961-0 AtroventHFA 1 in 1 CARTON AEROSOL, METERED 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0961 ATROVENT HFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [A-S MEDICATION SOLUTIONS] 11 Legacy NDC, 2 package rows 20190225_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Atrovent HFA IPRATROPIUM BROMIDE Boehringer Ingelheim Pharmaceuticals, Inc. 170e98ef-5560-4068-be7d-e649068eb884 2025-11-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 021527 application number: NDA021527
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-0961-0 50090096100 1 CANISTER in 1 CARTON (50090-0961-0) > 200 AEROSOL, METERED in 1 CANISTER 1 canister 2014-11-28 0000-00-00 No No Current