Xopenex

Product NDC: 21695-153
11-digit product format: 216950153
Labeler code: 21695
Product ID: 21695-153_35eb525b-72a5-4ef9-a36a-531e9e6b3560
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levalbuterol hydrochloride
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Rebel Distributors Corp
Application: NDA020837
Marketing category: NDA
Marketing start: 1999-04-01
Marketing end: 0000-00-00
Substance: LEVALBUTEROL HYDROCHLORIDE
Active strength: 1 mg/3mL
Pharmacologic classes: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-153		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-153	21695-153-24	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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`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	21695-153-24	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020837-001	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25
N020837-002	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25
N020837-003	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2002-01-30
N020837-004	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2003-07-18

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020837-001	XOPENEX	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020837-002	XOPENEX	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020837-003	XOPENEX	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2002-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020837-004	XOPENEX	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2003-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020837-001	XOPENEX	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020837-002	XOPENEX	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020837-003	XOPENEX	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2002-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020837-004	XOPENEX	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2003-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020837-001	XOPENEX	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020837-002	XOPENEX	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020837-003	XOPENEX	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2002-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020837-004	XOPENEX	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2003-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020837-001	XOPENEX	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020837-002	XOPENEX	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020837-003	XOPENEX	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2002-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020837-004	XOPENEX	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2003-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020837-001	XOPENEX	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020837-002	XOPENEX	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020837-003	XOPENEX	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2002-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020837-004	XOPENEX	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2003-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020837-001	XOPENEX	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020837-002	XOPENEX	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020837-003	XOPENEX	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2002-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020837-004	XOPENEX	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2003-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020837-001	XOPENEX	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020837-002	XOPENEX	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020837-003	XOPENEX	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2002-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020837-004	XOPENEX	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2003-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION	RLD	1999-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION	RLD	1999-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION	RLD	2002-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION	RLD	2003-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION	RLD	1999-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION	RLD	1999-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION	RLD	2002-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION	RLD	2003-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION	RLD	1999-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION	RLD	1999-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION	RLD	2002-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION	RLD	2003-07-18	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-002	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-003	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-004	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020837-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020837-002	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020837-003	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020837-004	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020837-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020837-002	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020837-003	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020837-004	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020837-001	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-002	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-003	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-004	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020837-001	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020837-002	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020837-003	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020837-004	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020837-001	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-002	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-003	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-004	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-001	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-002	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-003	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-004	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020837-001	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-002	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-003	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-004	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020837-001	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-002	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-003	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-004	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020837-001	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-002	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-003	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-004	AN	1	`c0c555d07b60…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020837-001	6451289	2021-03-21		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-002	6451289	2021-03-21		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-003	6451289	2021-03-21		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-004	6451289	2021-03-21	Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N020837-001	6451289	2021-03-21		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-002	6451289	2021-03-21		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-003	6451289	2021-03-21		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-004	6451289	2021-03-21	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-001	6451289	2021-03-21		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-002	6451289	2021-03-21		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-003	6451289	2021-03-21		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-004	6451289	2021-03-21	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020837-001	6451289	2021-03-21		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-002	6451289	2021-03-21		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-003	6451289	2021-03-21		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-004	6451289	2021-03-21	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020837-001	6451289	2021-03-21		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-002	6451289	2021-03-21		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-003	6451289	2021-03-21		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-004	6451289	2021-03-21	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020837-001	6451289	2021-03-21		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-002	6451289	2021-03-21		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-003	6451289	2021-03-21		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-004	6451289	2021-03-21	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020837-001	6451289	2021-03-21		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020837-002	6451289	2021-03-21		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020837-003	6451289	2021-03-21		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020837-004	6451289	2021-03-21	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020837-001	6451289	2021-03-21		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020837-002	6451289	2021-03-21		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020837-003	6451289	2021-03-21		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020837-004	6451289	2021-03-21	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020837-001	6451289	2021-03-21		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020837-002	6451289	2021-03-21		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020837-003	6451289	2021-03-21		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020837-004	6451289	2021-03-21	Drug product	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3b93cc5d-8105-47d8-8ae6-077d0f655880	Product name	3	20190213
415a13b7-458d-4b44-ab20-f56d8ef7ab9d	Product name	2	20170426
a511b237-73ca-80ef-2a42-a935d09028ad	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-153-24	2019-09-24	C162847	48780-1	934fe258-48ed-48b1-e053-8cdaa90a720a	Xopenex ® (levalbuterol HCl) Inhalation Solution 0.31 mg, 0.63 mg, 1.25 mg*

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-153-24	Xopenex	12 in 1 POUCH	SOLUTION	12		1
21695-153-24	Xopenex	2 in 1 CARTON	SOLUTION	2		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-153-24	ML - Milliliter	21695-153	d13e3830-3502-4c74-b148-072f224e7fd2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
levalbuterol hydrochloride	ACTIVE INGREDIENT	WDQ1526QJM	XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
levalbuterol	ACTIVE MOIETY	EDN2NBH5SS	XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
nitrogen	INACTIVE INGREDIENT	N762921K75	XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
sulfuric acid	INACTIVE INGREDIENT	O40UQP6WCF	XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-153	XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20101210_35eb525b-72a5-4ef9-a36a-531e9e6b3560.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WDQ1526QJM	LEVALBUTEROL HYDROCHLORIDE	50293-90-8	LEVALBUTEROL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
242754	levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution	PSN	35eb525b-72a5-4ef9-a36a-531e9e6b3560	1
833470	Xopenex 1.25 MG in 3 ML Inhalation Solution	PSN	35eb525b-72a5-4ef9-a36a-531e9e6b3560	1
833470	levalbuterol 0.417 MG/ML Inhalation Solution [Xopenex]	SBD	35eb525b-72a5-4ef9-a36a-531e9e6b3560	1
242754	levalbuterol 0.417 MG/ML Inhalation Solution	SCD	35eb525b-72a5-4ef9-a36a-531e9e6b3560	1
242754	levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution	SY	35eb525b-72a5-4ef9-a36a-531e9e6b3560	1
833470	Xopenex 0.417 MG/ML Inhalation Solution	SY	35eb525b-72a5-4ef9-a36a-531e9e6b3560	1
833470	Xopenex 1.25 MG (as levalbuterol hydrochloride 1.44 MG) per 3 ML Inhalation Solution	SY	35eb525b-72a5-4ef9-a36a-531e9e6b3560	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-153-24	21695015324	12 in 1 POUCH	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xopenex ® (levalbuterol HCl) Inhalation Solution 0.31 mg, 0.63 mg, 1.25 mg*	Rebel Distributors Corp	2010-12-01	HUMAN PRESCRIPTION DRUG LABEL	1