Levalbuterol tartrate HFA inhalation

Product NDC: 0591-2927
11-digit product format: 005912927
Labeler code: 0591
Product ID: 0591-2927_f9039b6c-2ae3-416b-bc2a-ab6e06e830bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levalbuterol tartrate
Dosage form: AEROSOL, METERED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: NDA021730
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-10-03
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: Levalbuterol tartrate HFA inhalation
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
745791	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
ac85703a-17a2-4f0b-87f4-78f1756d2f85	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
0591-2927-54	Levalbuterol tartrate HFA inhalation	1 in 1 CARTON	AEROSOL, METERED	1		20
0591-2927-54	Levalbuterol tartrate HFA inhalation	200 in 1 INHALER	AEROSOL, METERED	200		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2927-54	GM - Gram	0591-2927	b88dfbe0-c468-46a3-b4fc-6d7a883ae273	1	2016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TETRACYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	P6R62377KV	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
TETRACYCLINE	ACTIVE MOIETY	F8VB5M810T	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
ETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	IDK7C2HS09	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2927	LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE) AEROSOL, METERED [ACTAVIS PHARMA, INC.]	20	Current NDC, Legacy NDC, 2 package rows	20231026_ac85703a-17a2-4f0b-87f4-78f1756d2f85.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
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 ndc (product): 0591-2927
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	ac85703a-17a2-4f0b-87f4-78f1756d2f85	20
745791	200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler	SCD	ac85703a-17a2-4f0b-87f4-78f1756d2f85	20
745791	levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	ac85703a-17a2-4f0b-87f4-78f1756d2f85	20
745791	levalbuterol 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	ac85703a-17a2-4f0b-87f4-78f1756d2f85	20
745791	levalbuterol 45 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN	a469689a-e64e-4117-b94a-c8b730abda1a	4
745791	200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler	SCD	a469689a-e64e-4117-b94a-c8b730abda1a	4
745791	levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	a469689a-e64e-4117-b94a-c8b730abda1a	4
745791	levalbuterol 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY	a469689a-e64e-4117-b94a-c8b730abda1a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2927-54	00591292754	1 INHALER in 1 CARTON (0591-2927-54) / 200 AEROSOL, METERED in 1 INHALER	1 inhaler	2016-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levalbuterol tartrate HFA inhalation - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	102
Levalbuterol tartrate HFA inhalation - Actavis Pharma, Inc.	Actavis Pharma, Inc.	2023-07-01	HUMAN PRESCRIPTION DRUG LABEL	20
Levalbuterol tartrate HFA inhalation - Proficient Rx LP	Proficient Rx LP	2022-12-01	HUMAN PRESCRIPTION DRUG LABEL	4
Levalbuterol tartrate HFA inhalation - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2019-10-14	HUMAN PRESCRIPTION DRUG LABEL	4