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LATANOPROST

These highlights do not include all the information needed to use LATANOPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for LATANOPROST OPHTHALMIC SOLUTION. LATANOPROST ophthalmic solution, 0.005%Initial U.S. Approval: 1996

Approved
Approval ID

5d0b99ad-f05a-44c7-ac61-26b5a533ea8d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 9, 2023

Manufacturers
FDA

Somerset Therapeutics, LLC

DUNS: 079947873

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LATANOPROST

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70069-421
Application NumberANDA201786
Product Classification
M
Marketing Category
C73584
G
Generic Name
LATANOPROST
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 9, 2023
FDA Product Classification

INGREDIENTS (5)

LATANOPROSTActive
Quantity: 50 ug in 1 mL
Code: 6Z5B6HVF6O
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT

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