XOPENEX HFA

Product NDC: 27437-056
11-digit product format: 274370056
Labeler code: 27437
Product ID: 27437-056_905559df-c984-469d-b6b1-a38fdc320471
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levalbuterol tartrate
Dosage form: AEROSOL, METERED
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: NDA021730
Marketing category: NDA
Marketing start: 2023-11-10
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: XOPENEX HFA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVALBUTEROL TARTRATE	45 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ADS4I3E22M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
745791	Internal RxNorm lookup
746466	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
70a35706-d7a8-4a48-98c6-1cab1c42fe8d	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27437-056-01	XOPENEX HFA	1 in 1 CARTON	AEROSOL, METERED	1		3
27437-056-01	XOPENEX HFA	200 in 1 INHALER	AEROSOL, METERED	200		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27437-056-01	GM - Gram	27437-056	c2778936-5305-4b28-8412-0f48f4aae28e	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27437-056	XOPENEX HFA (LEVALBUTEROL TARTRATE) AEROSOL, METERED [LUPIN PHARMACEUTICALS, INC.]	2	Current NDC, 2 package rows	20240316_70a35706-d7a8-4a48-98c6-1cab1c42fe8d.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 · 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 ndc (product): 27437-056
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	70a35706-d7a8-4a48-98c6-1cab1c42fe8d	3
746466	Xopenex HFA 45 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	70a35706-d7a8-4a48-98c6-1cab1c42fe8d	3
746466	200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler [Xopenex]	SBD	70a35706-d7a8-4a48-98c6-1cab1c42fe8d	3
745791	200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler	SCD	70a35706-d7a8-4a48-98c6-1cab1c42fe8d	3
745791	levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	70a35706-d7a8-4a48-98c6-1cab1c42fe8d	3
745791	levalbuterol 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	70a35706-d7a8-4a48-98c6-1cab1c42fe8d	3
746466	Xopenex 0.045 MG/ACTUAT (levalbuterol tartrate 0.059 MG/ACTUAT) Metered Dose Inhaler, 200 ACTUAT	SY	70a35706-d7a8-4a48-98c6-1cab1c42fe8d	3
746466	Xopenex 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	70a35706-d7a8-4a48-98c6-1cab1c42fe8d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
27437-056-01	27437005601	1 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALER	1 inhaler	2023-11-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XOPENEX HFA - Lupin Pharmaceuticals, Inc.	Lupin Pharmaceuticals, Inc.	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	3