Ipratropium Bromide and Albuterol Sulfate

Product NDC
0185-7322
11-digit product format
001857322
Labeler code
0185
Product ID
0185-7322_033ee32c-9a53-4fdd-ac28-dddce389fb60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide and albuterol sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Eon Labs, Inc.
Application
NDA020950
Marketing category
NDA
Marketing start
2001-03-21
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE; ALBUTEROL SULFATE
Active strength
1 mg/3mL; mg/3mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0185-7322DDiscontinued by firm2026-08-03
excluded packagepackage0185-73220185-7322-13DDiscontinued by firm2026-08-03
excluded packagepackage0185-73220185-7322-30DDiscontinued by firm2026-08-03
excluded packagepackage0185-73220185-7322-60DDiscontinued 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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-7322-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-7322-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-7322-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-7322-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-7322-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-7322-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-7322-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-7322-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-7322-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-7322-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-7322-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-7322-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-7322-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-7322-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-7322-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-7322-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-7322-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-7322-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-7322-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-7322-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-7322-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-7322-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-7322-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-7322-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-7322-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-7322-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-7322-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-7322-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-7322-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-7322-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-7322-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-7322-13367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-7322-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-7322-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-7322-13557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-7322-30557ba5c1ecfa…9c80585c8c6e…

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
N020950-001DUONEBALBUTEROL SULFATE; IPRATROPIUM BROMIDEEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21

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 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 UTC2026-02N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020950-001DUONEBEQ 0.083% BASE;0.017%SOLUTION / INHALATIONRLD2001-03-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020950-001DUONEBEQ 0.083% BASE;0.017%SOLUTION / INHALATIONRLD2001-03-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INHALATIONRLD2001-03-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INHALATIONRLD2001-03-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INHALATIONRLD2001-03-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INHALATIONRLD2001-03-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INHALATIONRLD2001-03-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INHALATIONRLD2001-03-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INHALATIONRLD2001-03-213f01610625f2…
2019-09-15 20:21 UTC2019-09N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INHALATIONRLD2001-03-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / INHALATIONRLD2001-03-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020950-001DUONEBEQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INHALATIONRLD2001-03-21cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020950-00166328422021-12-28U-53274a2ff9319b5…
2021-12-28 21:50 UTC2021-12N020950-00166328422021-12-28U-532782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020950-00166328422021-12-28U-53287673890dc5c…
2021-03-12 10:30 UTC2021-03N020950-00166328422021-12-28U-5325aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020950-00166328422021-12-28U-5328869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020950-00166328422021-12-28U-532c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020950-00166328422021-12-28U-5323f01610625f2…
2019-09-15 20:21 UTC2019-09N020950-00166328422021-12-28U-532b00525d2431f…
2019-07-19 19:46 UTC2019-07N020950-00166328422021-12-28U-532ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36cProduct name220251106
d953267a-4ca0-4d44-91ad-712cdee8ab38Product name220250630
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
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-7322-13ML - Milliliter0185-73228fc4e26e-ec2f-4e97-8540-86a9e18e3d2612012-07-24
0185-7322-30ML - Milliliter0185-7322b84b5f12-4b7e-44a7-834b-5065a4b8619012012-07-24
0185-7322-60ML - Milliliter0185-73229fbc8539-aaed-4404-a80d-5a53240d5b8a12012-07-24

DailyMed Socrata Ingredients#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437702ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation SolutionPSN8bcc115b-88da-4ff0-b4e1-ef10d5287e541
1437702albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation SolutionSCD8bcc115b-88da-4ff0-b4e1-ef10d5287e541
1437702albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation SolutionSY8bcc115b-88da-4ff0-b4e1-ef10d5287e541