Xopenex HFA

Product NDC: 63402-510
Requested package NDC: 63402-510-01
11-digit product format: 634020510
Labeler code: 63402
Product ID: 63402-510_bdfdcf19-9165-4b49-9cf2-505e7c107e57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levalbuterol tartrate
Dosage form: AEROSOL, METERED
Route: ORAL
Labeler: Sunovion Pharmaceuticals Inc.
Application: NDA021730
Marketing category: NDA
Marketing start: 2005-12-01
Marketing end: 0000-00-00
Substance: LEVALBUTEROL TARTRATE
Active strength: 45 ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63402-510	63402-510-01	D	Discontinued by firm		2026-08-11

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021730-001	XOPENEX HFA	LEVALBUTEROL TARTRATE	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION		RLD, RS	2005-03-11

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021730-001	XOPENEX HFA	EQ 0.045MG BASE/INH	AEROSOL, METERED / INHALATION	RLD, RS	2005-03-11	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021730-001	7256310	2024-10-08	U-636	Drug substance, Drug product		`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021730-001	8765153	2023-12-08		Drug product	2014-07-28	`a72a2bbeb626…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63402-510-01	GM - Gram	63402-510	5d04024f-da45-4d5a-9c63-8824c6a3fa6c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
levalbuterol tartrate	ACTIVE INGREDIENT	ADS4I3E22M	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [SUNOVION PHARMACEUTICALS INC.]	12
levalbuterol	ACTIVE MOIETY	EDN2NBH5SS	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [SUNOVION PHARMACEUTICALS INC.]	12
alcohol	INACTIVE INGREDIENT	3K9958V90M	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [SUNOVION PHARMACEUTICALS INC.]	12
norflurane	INACTIVE INGREDIENT	DH9E53K1Y8	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [SUNOVION PHARMACEUTICALS INC.]	12
Oleic Acid	INACTIVE INGREDIENT	2UMI9U37CP	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [SUNOVION PHARMACEUTICALS INC.]	12
levalbuterol tartrate	ACTIVE INGREDIENT	ADS4I3E22M	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]	1
levalbuterol	ACTIVE MOIETY	EDN2NBH5SS	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]	1
norflurane	INACTIVE INGREDIENT	DH9E53K1Y8	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]	1
Oleic Acid	INACTIVE INGREDIENT	2UMI9U37CP	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]	1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XOPENEX HFA	LEVALBUTEROL TARTRATE	Lupin Pharmaceuticals, Inc.	70a35706-d7a8-4a48-98c6-1cab1c42fe8d	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021730 application number: NDA021730
Levalbuterol tartrate HFA inhalation	LEVALBUTEROL TARTRATE	Actavis Pharma, Inc.	ac85703a-17a2-4f0b-87f4-78f1756d2f85	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021730 application number: NDA021730
Levalbuterol tartrate HFA inhalation	LEVALBUTEROL TARTRATE	Proficient Rx LP	a469689a-e64e-4117-b94a-c8b730abda1a	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021730 application number: NDA021730

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ADS4I3E22M	LEVALBUTEROL TARTRATE	661464-94-4	LEVALBUTEROL TARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
745791	levalbuterol 45 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	320fea02-8aa3-44c8-b52a-a118418d1f78	1
746466	Xopenex HFA 45 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	320fea02-8aa3-44c8-b52a-a118418d1f78	1
746466	200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler [Xopenex]	SBD	320fea02-8aa3-44c8-b52a-a118418d1f78	1
745791	200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler	SCD	320fea02-8aa3-44c8-b52a-a118418d1f78	1
745791	levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	320fea02-8aa3-44c8-b52a-a118418d1f78	1
745791	levalbuterol 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	320fea02-8aa3-44c8-b52a-a118418d1f78	1
746466	Xopenex 0.045 MG/ACTUAT (levalbuterol tartrate 0.059 MG/ACTUAT) Metered Dose Inhaler, 200 ACTUAT	SY	320fea02-8aa3-44c8-b52a-a118418d1f78	1
746466	Xopenex 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	320fea02-8aa3-44c8-b52a-a118418d1f78	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63402-510-01	63402051001	1 INHALER in 1 CARTON (63402-510-01) > 200 AEROSOL, METERED in 1 INHALER	1 inhaler	2005-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xopenex HFA - Sumitomo Pharma America, Inc.	Sumitomo Pharma America, Inc.	2023-10-24	HUMAN PRESCRIPTION DRUG LABEL	21
XOPENEX HFA ® (levalbuterol tartrate) Inhalation Aerosol	Physicians Total Care, Inc.	2012-05-07	HUMAN PRESCRIPTION DRUG LABEL	1