Ipratropium Bromide

Product NDC
21695-911
11-digit product format
216950911
Labeler code
21695
Product ID
21695-911_46b4392a-47dd-47b5-9f99-13e4c188faa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Rebel Distributors Corp
Application
ANDA076291
Marketing category
ANDA
Marketing start
2005-05-09
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE
Active strength
1 mg/2.5mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-911IInactivated by FDA2026-08-17
excluded packagepackage21695-91121695-911-25IInactivated by FDA2026-08-17
excluded packagepackage21695-91121695-911-30IInactivated by FDA2026-08-17

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 2 · 66 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 packagepackage21695-911-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-911-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-911-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-911-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-911-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-911-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-911-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-911-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-911-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-911-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-911-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-911-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-911-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-911-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-911-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-911-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-911-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-911-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-911-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-911-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-911-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-911-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-911-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-911-25557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-911-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-911-258af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-911-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-911-25834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-911-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-911-251332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-911-30fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-911-25fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-911-3086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-911-2586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-911-30bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-911-25bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-911-308dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-911-258dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-911-30e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-911-25e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076291-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONAN2005-05-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONAN2005-05-093f01610625f2…
2019-09-15 20:21 UTC2019-09A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONAN2005-05-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONAN2005-05-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076291-001AN174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076291-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09A076291-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076291-001AN1ea99ee380514…

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
21695-911-252019-09-24C16284748780-1934fe258-4878-48b1-e053-8cdaa90a720a46b4392a-47dd-47b5-9f99-13e4c188faa4
21695-911-302019-09-24C16284748780-1934fe258-4878-48b1-e053-8cdaa90a720a46b4392a-47dd-47b5-9f99-13e4c188faa4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-911-25Ipratropium Bromide1 in 1 CARTONSOLUTION11
21695-911-25Ipratropium Bromide25 in 1 POUCHSOLUTION251
21695-911-30Ipratropium Bromide1 in 1 CARTONSOLUTION11
21695-911-30Ipratropium Bromide30 in 1 POUCHSOLUTION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-911-25ML - Milliliter21695-911c1a01bd3-fceb-428b-92d5-8a9c2184c57012012-07-24
21695-911-30ML - Milliliter21695-911b4a9214b-5983-4c5a-a562-79afc17e275e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ipratropium BromideACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-911IPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20101201_46b4392a-47dd-47b5-9f99-13e4c188faa4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN46b4392a-47dd-47b5-9f99-13e4c188faa41
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD46b4392a-47dd-47b5-9f99-13e4c188faa41
836358ipratropium bromide 0.02 % Inhalation SolutionSY46b4392a-47dd-47b5-9f99-13e4c188faa41
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY46b4392a-47dd-47b5-9f99-13e4c188faa41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-911-25216950911251 in 1 CARTONHistorical
21695-911-30216950911301 in 1 CARTONHistorical