Atrovent

Product NDC: 53002-8410
11-digit product format: 530028410
Labeler code: 53002
Product ID: 53002-8410_ae30f199-16cf-4645-8ca6-01afb7157083
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ipratropium bromide
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: RPK Pharmaceuticals, Inc.
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: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53002-8410		I	Inactivated by FDA		2026-08-17
excluded package	package	53002-8410	53002-8410-1	I	Inactivated by FDA		2026-08-17

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 1 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-8410-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-8410-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-8410-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-8410-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-8410-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-8410-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-8410-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-8410-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-8410-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-8410-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-8410-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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-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 · 42 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
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
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…`
2019-07-19 19:46 UTC	2019-07	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36c	Product name	2	20251106
d953267a-4ca0-4d44-91ad-712cdee8ab38	Product name	2	20250630
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
6ac73021-459f-435b-b6c5-8c7d6a50c021	Product name	2	20170404

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	These highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
2023-06-08	These highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
2023-01-30	These highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
2020-12-17	These highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
2020-01-31	These highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-8410-1	AtroventHFA	1 in 1 CARTON	AEROSOL, METERED	1		5
53002-8410-1	AtroventHFA	200 in 1 CANISTER	AEROSOL, METERED	200		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-8410	ATROVENT HFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 2 package rows	20230609_ae462cd6-615b-4f0d-ae6e-59007e7acab0.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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J697UZ2A9J	IPRATROPIUM BROMIDE	66985-17-9	IPRATROPIUM BROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
836368	Atrovent HFA 17 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	ae462cd6-615b-4f0d-ae6e-59007e7acab0	5
836343	ipratropium bromide 17 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	ae462cd6-615b-4f0d-ae6e-59007e7acab0	5
836368	200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler [Atrovent]	SBD	ae462cd6-615b-4f0d-ae6e-59007e7acab0	5
836343	200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler	SCD	ae462cd6-615b-4f0d-ae6e-59007e7acab0	5
836368	200 ACTUAT Atrovent HFA 0.017 MG/ACTUAT Metered Dose Inhaler	SY	ae462cd6-615b-4f0d-ae6e-59007e7acab0	5
836368	Atrovent 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	ae462cd6-615b-4f0d-ae6e-59007e7acab0	5
836368	Atrovent HFA 17 MCG per ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	ae462cd6-615b-4f0d-ae6e-59007e7acab0	5
836343	ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	ae462cd6-615b-4f0d-ae6e-59007e7acab0	5
836343	ipratropium bromide 17 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	ae462cd6-615b-4f0d-ae6e-59007e7acab0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-8410-1	53002841001	1 CANISTER in 1 CARTON (53002-8410-1) > 200 AEROSOL, METERED in 1 CANISTER	1 canister	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atrovent HFA - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5