levalbuterol inhalation
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. FOR ORAL INHALATION ONLY
Approved
Approval ID
163dfa7c-aad3-4290-9fe9-d9592b0ba317
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2014
Manufacturers
FDA
Dr. Reddys Laboratories, Inc.
DUNS: 802315887
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levalbuterol inhalation 1.25mg/3mL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-409
Application NumberANDA078171
Product Classification
M
Marketing Category
C73584
G
Generic Name
levalbuterol inhalation 1.25mg/3mL
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 16, 2014
FDA Product Classification
INGREDIENTS (6)
LevalbuterolActive
Quantity: 1.25 mg in 3 mL
Code: EDN2NBH5SS
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sulfuric AcidInactive
Code: O40UQP6WCF
Classification: IACT
NitrogenInactive
Code: N762921K75
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
levalbuterol inhalation 0.31mg/3mL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-412
Application NumberANDA078171
Product Classification
M
Marketing Category
C73584
G
Generic Name
levalbuterol inhalation 0.31mg/3mL
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 16, 2014
FDA Product Classification
INGREDIENTS (6)
LevalbuterolActive
Quantity: 0.31 mg in 3 mL
Code: EDN2NBH5SS
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sulfuric AcidInactive
Code: O40UQP6WCF
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
NitrogenInactive
Code: N762921K75
Classification: IACT
levalbuterol inhalation 0.63mg/3mL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-410
Application NumberANDA078171
Product Classification
M
Marketing Category
C73584
G
Generic Name
levalbuterol inhalation 0.63mg/3mL
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 16, 2014
FDA Product Classification
INGREDIENTS (6)
LevalbuterolActive
Quantity: 0.63 mg in 3 mL
Code: EDN2NBH5SS
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Sulfuric AcidInactive
Code: O40UQP6WCF
Classification: IACT
NitrogenInactive
Code: N762921K75
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT