Ipratropium Bromide

Product NDC
0591-3798
Requested package NDC
0591-3798-60
11-digit product format
005913798
Labeler code
0591
Product ID
0591-3798_cdc5d8b0-a363-4896-996c-10a592370db9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Actavis Pharma, Inc.
Application
ANDA075693
Marketing category
ANDA
Marketing start
2011-03-01
Marketing end
2022-04-30
Substance
IPRATROPIUM BROMIDE
Active strength
1 mg/2.5mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage0591-37980591-3798-60DDiscontinued by firm2026-09-14

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 · 12 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…

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
A075693-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075693-001AN

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 22:38:342026-08A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2684e616aacf4f…
2026-08-18 06:07:402026-07A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-263f01610625f2…
2019-09-15 20:21 UTC2019-09A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075693-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONANRS2001-01-26f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075693-001AN184e616aacf4f…
2026-08-18 06:07:402026-07A075693-001AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075693-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075693-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075693-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075693-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075693-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075693-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075693-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075693-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075693-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075693-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075693-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075693-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075693-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075693-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075693-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075693-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075693-001AN14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075693-001AN174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075693-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075693-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075693-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03A075693-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075693-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075693-001AN1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075693-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A075693-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075693-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075693-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075693-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075693-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075693-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075693-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075693-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075693-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075693-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075693-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075693-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075693-001AN1f41ea6bd6efb…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3798-30ML - Milliliter0591-37980ce7c849-95b4-443a-a0c7-de5fb378c69712012-07-24
0591-3798-60ML - Milliliter0591-3798c0af4c9a-57a0-4a4d-9cd6-aa7d19cf4e8712012-07-24
0591-3798-83ML - Milliliter0591-3798ba98e452-fc74-442f-b42a-2a3efc95f20712012-07-24

DailyMed Socrata Ingredients#

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC6b730dd7-4d93-403a-bfd2-fa0efa298b752026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC51350fab-a919-4d97-9d0c-d9dc7286244c2026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDERedpharm Drug52c63e41-dbbc-d9d7-e063-6294a90a30c92026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDERitedose Pharmaceuticals, LLC22479633-624a-4251-ad3c-1dcba5d503fb2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDENuCare Pharmaceuticals, Inc.2b9b619a-5e2a-73ef-e063-6394a90a97fe2025-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions7159cf05-da58-4eb9-9e6d-a7f24eec5f462025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEAmerican Health Packaging8927f392-4c88-4ac1-a934-c444ecf6b2c82024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions9f7b2f09-e831-4e15-b226-5cef3b613bd12023-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693
Ipratropium BromideIPRATROPIUM BROMIDEMylan Pharmaceuticals Inc.f625d3e3-c175-4d9a-99ea-dab410b262f12013-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075693
application number: ANDA075693

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN95990ec1-9cfd-4b94-afbd-7ced6ecca5671
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD95990ec1-9cfd-4b94-afbd-7ced6ecca5671
836358ipratropium bromide 0.02 % Inhalation SolutionSY95990ec1-9cfd-4b94-afbd-7ced6ecca5671
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY95990ec1-9cfd-4b94-afbd-7ced6ecca5671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3798-60005913798602 POUCH in 1 CARTON (0591-3798-60) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL2 pouch2011-03-012022-01-31NoNoCurrent