Latanoprost Ophthalmic Solution 50 ug/mL
Latanoprost Ophthalmic Solution · SOLUTION/ DROPS · Lifestar Pharma LLC
Latanoprost Ophthalmic Solution is a solution/ drops containing latanoprost ophthalmic solution at 50 ug/mL, taken ophthalmic. Manufactured by Lifestar Pharma LLC.
Key Facts
- Brand Name
- Latanoprost Ophthalmic Solution
- Generic Name
- Latanoprost Ophthalmic Solution
- NDC Code (Product)
70756-680- Manufacturer
- Lifestar Pharma LLC
- Strength
- 50 ug/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA220360
- Drug Class
- Prostaglandin Analog [EPC]
- Marketing Start
- 03/01/2026
Recall History
Akorn, Inc.
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Apotex Inc
Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. The dosage of latanoprost ophthalmic solution should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including latanoprost ophthalmic solution is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. Latanoprost ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with latanoprost ophthalmic solution. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Contact lenses should be removed prior to the administration of latanoprost ophthalmic solution, and may be reinsert…
Contraindications
4 CONTRAINDICATIONS Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. (4)
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label: Iris pigmentation changes [see Warnings and Precautions (5.1)] Eyelid skin darkening [see Warnings and Precautions (5.1)] Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions (5.2)] Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions (5.3)] Macular edema, including cystoid macular edema [see Warnings and Precautions (5.4)] Most common adverse reactions (5-15%) from clinical trials are blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate keratitis. (6) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials o…
Frequently Asked Questions
What is Latanoprost Ophthalmic Solution used for?
Latanoprost Ophthalmic Solution contains Latanoprost Ophthalmic Solution. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Latanoprost Ophthalmic Solution a controlled substance?
Latanoprost Ophthalmic Solution is not classified as a controlled substance by the DEA.
What is the generic name for Latanoprost Ophthalmic Solution?
The generic name for Latanoprost Ophthalmic Solution is Latanoprost Ophthalmic Solution. There are 1 other brand versions of Latanoprost Ophthalmic Solution.
What is the NDC code for Latanoprost Ophthalmic Solution 50 ug/mL?
The NDC (National Drug Code) for Latanoprost Ophthalmic Solution 50 ug/mL is 70756-680, listed by Lifestar Pharma LLC.