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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

88efde63-9a7e-5b29-e053-2a95a90ae4cb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 29, 2021

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

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 Code68071-4893
Application NumberANDA202442
Product Classification
M
Marketing Category
C73584
G
Generic Name
latanoprost
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 29, 2021
FDA Product Classification

INGREDIENTS (5)

BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
LATANOPROSTActive
Quantity: 50 ug in 1 mL
Code: 6Z5B6HVF6O
Classification: ACTIB

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