Phenylephrine Hydrochloride
These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP.PHENYLEPHRINE HYDROCHLORIDE ophthalmic solution, USP 2.5% and 10%.Initial U.S. Approval: 1939
Approved
Approval ID
49558551-cbed-4518-a6d4-16cfd893eab0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Akorn
DUNS: 117693100
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenylephrine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-201
Application NumberNDA207926
Product Classification
M
Marketing Category
C73594
G
Generic Name
Phenylephrine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (7)
Phenylephrine HydrochlorideActive
Quantity: 25 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
Sodium Phosphate, Dibasic, AnhydrousInactive
Code: 22ADO53M6F
Classification: IACT
Phosphoric AcidInactive
Code: E4GA8884NN
Classification: IACT
Sodium Phosphate, Monobasic, AnhydrousInactive
Code: KH7I04HPUU
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Phenylephrine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-206
Application NumberNDA207926
Product Classification
M
Marketing Category
C73594
G
Generic Name
Phenylephrine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (7)
Phenylephrine HydrochlorideActive
Quantity: 100 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
Sodium Phosphate, Dibasic, AnhydrousInactive
Code: 22ADO53M6F
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium Phosphate, Monobasic, AnhydrousInactive
Code: KH7I04HPUU
Classification: IACT
Phosphoric AcidInactive
Code: E4GA8884NN
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT