Ipratropium Bromide

Product NDC: 42254-355
11-digit product format: 422540355
Labeler code: 42254
Product ID: 42254-355_09ab5bc2-645f-415d-ad76-246385690176
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ipratropium Bromide
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Rebel Distributors Corp
Application: ANDA076103
Marketing category: ANDA
Marketing start: 2003-03-31
Marketing end: 0000-00-00
Substance: IPRATROPIUM BROMIDE
Active strength: 42 ug/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42254-355		I	Inactivated by FDA		2026-08-17
excluded package	package	42254-355	42254-355-15	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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-355-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-355-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-355-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-355-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-355-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-355-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-355-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-355-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-355-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-355-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-355-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-355-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-355-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-355-15	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-355-15	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-355-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-355-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-355-15	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-355-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-355-15	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-355-15	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-355-15	`110d247fa046…`	`a55b01930146…`

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
A076103-001	IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB		2003-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076103-001	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076103-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-03-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076103-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076103-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076103-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076103-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076103-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076103-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076103-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076103-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076103-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076103-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076103-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076103-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076103-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076103-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076103-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076103-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076103-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076103-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076103-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076103-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076103-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076103-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076103-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076103-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076103-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076103-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076103-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076103-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076103-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076103-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076103-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076103-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076103-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076103-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076103-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076103-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076103-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076103-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076103-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076103-001	AB	1	`e64feba35796…`

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
6ac73021-459f-435b-b6c5-8c7d6a50c021	Product name	2	20170404
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-355-15	2019-09-24	C162847	48780-1	9350213a-3cc5-c013-e053-90daa90a1393	Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-355-15	Ipratropium Bromide	165 in 1 BOTTLE, SPRAY	SPRAY, METERED	165		1
42254-355-15	Ipratropium Bromide	1 in 1 CARTON	SPRAY, METERED	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-355-15	ML - Milliliter	42254-355	b718a927-7c52-44b6-b7ab-78197cf38abc	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IPRATROPIUM BROMIDE	ACTIVE INGREDIENT	J697UZ2A9J	IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
IPRATROPIUM	ACTIVE MOIETY	GR88G0I6UL	IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-355	IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20130221_09ab5bc2-645f-415d-ad76-246385690176.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ipratropium Bromide	IPRATROPIUM BROMIDE	Oceanside Pharmaceuticals	b1a5e41a-9100-41d5-a7d0-2e763ad5efb6	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076103 application number: ANDA076103
Ipratropium Bromide	IPRATROPIUM BROMIDE	Bausch & Lomb Incorporated	3fd850a2-af0f-4291-af5d-52c8d6094e64	2019-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076103 application number: ANDA076103

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
1797844	ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal Spray	PSN	09ab5bc2-645f-415d-ad76-246385690176	1
1797844	ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal Spray	SCD	09ab5bc2-645f-415d-ad76-246385690176	1
1797844	ipratropium bromide 0.06 % Metered Dose Nasal Spray	SY	09ab5bc2-645f-415d-ad76-246385690176	1
1797844	ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal Spray	SY	09ab5bc2-645f-415d-ad76-246385690176	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-355-15	42254035515	165 in 1 BOTTLE, SPRAY	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-12-11	HUMAN PRESCRIPTION DRUG LABEL	1