Levalbuterol Hydrochloride

Product NDC: 76204-003
11-digit product format: 762040003
Labeler code: 76204
Product ID: 76204-003_f54c79f2-308f-4c04-8a6f-186fbc90bb8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levalbuterol Hydrochloride
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Ritedose Pharmaceuticals, LLC
Application: NDA020837
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-12-01
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: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76204-003		I	Inactivated by FDA		2026-07-31
excluded package	package	76204-003	76204-003-24	I	Inactivated by FDA		2026-07-31

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XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25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XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25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XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2002-01-30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XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2003-07-18

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76204-003-24	2020-01-31	C162847	48780-1	9d75b9d0-ebe7-f424-e053-dadaa90a57ce	6925ab5e-4f50-4d04-b55a-8a6f74474382

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76204-003-24	Levalbuterol Hydrochloride	2 in 1 CARTON	SOLUTION	2		1
76204-003-24	Levalbuterol Hydrochloride	12 in 1 POUCH	SOLUTION	12		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76204-003-24	ML - Milliliter	76204-003	c4e40156-3750-456d-a2f2-62a9c9ee8b9e	1	2013-03-03

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Levalbuterol Hydrochloride	ACTIVE INGREDIENT	WDQ1526QJM	LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	1
Levalbuterol	ACTIVE MOIETY	EDN2NBH5SS	LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	1
Sulfuric Acid	INACTIVE INGREDIENT	O40UQP6WCF	LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76204-003	LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	1	Legacy NDC, 2 package rows	20121227_6925ab5e-4f50-4d04-b55a-8a6f74474382.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311286	levalbuterol HCl 0.63 MG in 3 ML Inhalation Solution	PSN	6925ab5e-4f50-4d04-b55a-8a6f74474382	1
242754	levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution	PSN	6925ab5e-4f50-4d04-b55a-8a6f74474382	1
311286	levalbuterol 0.21 MG/ML Inhalation Solution	SCD	6925ab5e-4f50-4d04-b55a-8a6f74474382	1
242754	levalbuterol 0.417 MG/ML Inhalation Solution	SCD	6925ab5e-4f50-4d04-b55a-8a6f74474382	1
311286	levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation Solution	SY	6925ab5e-4f50-4d04-b55a-8a6f74474382	1
242754	levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution	SY	6925ab5e-4f50-4d04-b55a-8a6f74474382	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
76204-003-24	76204000324	2 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levalbuterol Hydrochloride - Ritedose Pharmaceuticals, LLC	Ritedose Pharmaceuticals, LLC	2012-12-14	HUMAN PRESCRIPTION DRUG LABEL	1