Xalatan

Manufacturer: PFIZER LABORATORIES DIV PFIZER INC
Effective date: 2022-12-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 25
Source: full-release
Hydrated at: 2026-05-31 21:15:37

Label at a glance#

ProductXalatan

Active ingredientLATANOPROST

Label structure15 sections

Indications and uses

XALATAN is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

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 XALATAN should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including XALATAN is not recommended. It has been shown that administration of these prostaglandin drug products more than once ...

Storage and handling

XALATAN is a clear, isotonic, buffered, preserved colorless solution of latanoprost 50 mcg/mL (0.005%). It is supplied as a 2.5 mL solution in a 5 mL clear low density polyethylene bottle with a clear polyethylene dropper tip, a turquoise high density polyethylene screw cap, and a tamper-evident clear low density polyethylene overcap. 2.5 mL fill, 50 mcg/mL (0.005%): Package of 1 bottle: NDC 0013-8303-04 Storage: ...

Contacts and useful links#

PhoneLabel contact1-800-438-1985

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Websitewww.pfizer.com

www.pfizer.com

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

XALATAN is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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 XALATAN should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including XALATAN 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.

XALATAN 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 XALATAN. 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 XALATAN, and may be reinserted 15 minutes after administration.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%).

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

5.1 Pigmentation

SPL UNCLASSIFIED SECTION

XALATAN has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered.

The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. Beyond 5 years the effects of increased pigmentation are not known [see Clinical Studies (14.2)].

Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with XALATAN can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

5.2 Eyelash Changes

SPL UNCLASSIFIED SECTION

XALATAN may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment.

5.3 Intraocular Inflammation

SPL UNCLASSIFIED SECTION

XALATAN should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation because inflammation may be exacerbated.

5.4 Macular Edema

SPL UNCLASSIFIED SECTION

Macular edema, including cystoid macular edema, has been reported during treatment with XALATAN. XALATAN should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

5.5 Herpetic Keratitis

SPL UNCLASSIFIED SECTION

Reactivation of herpes simplex keratitis has been reported during treatment with XALATAN. XALATAN should be used with caution in patients with a history of herpetic keratitis. XALATAN should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.

5.6 Bacterial Keratitis

SPL UNCLASSIFIED SECTION

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

5.7 Contact Lens Use

SPL UNCLASSIFIED SECTION

XALATAN contains benzalkonium chloride, which may be absorbed by contact lenses. Contact lenses should be removed prior to the administration of XALATAN, and may be reinserted 15 minutes after administration.

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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)]

6.1 Clinical Trials Experience

SPL UNCLASSIFIED SECTION

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 of another drug and may not reflect the rates observed in clinical practice.

XALATAN was studied in three multicenter, randomized, controlled clinical trials. Patients received 50 mcg/mL XALATAN once daily or 5 mg/mL active-comparator (timolol) twice daily. The patient population studied had a mean age of 65±10 years. Seven percent of patients withdrew before the 6-month endpoint.

Table 1: Ocular Adverse Reactions and Ocular Signs/Symptoms Reported by 5-15% of Patients Receiving Latanoprost
Symptom/Finding	Adverse Reactions (incidence (%))
Symptom/Finding	Latanoprost (n=460)	Timolol (n=369)
Foreign body sensation	13	8
Punctate keratitis	10	9
Stinging	9	12
Conjunctival hyperemia	8	3
Blurred vision	8	8
Itching	8	8
Burning	7	8
Increased pigmentation of the Iris	7	0

Less than 1% of the patients treated with XALATAN required discontinuation of therapy because of intolerance to conjunctival hyperemia.

Table 2: Adverse Reactions That Were Reported in 1-5% of Patients Receiving Latanoprost
	Adverse Reactions (incidence (%))
	Latanoprost (n=460)	Timolol (n=369)
Ocular Events/Signs and Symptoms
Excessive tearing	4	6
Eyelid discomfort/pain	4	2
Dry eye	3	3
Eye pain	3	3
Eyelid margin crusting	3	3
Erythema of the eyelid	3	2
Photophobia	2	1
Eyelid edema	1	3
Blepharitis	1	3
Systemic Events
Upper respiratory tract infection/nasopharyngitis/influenza	3	3
Myalgia/arthralgia/back pain	1	0.5
Rash/allergic skin reaction	1	0.3

6.2 Postmarketing Experience

SPL UNCLASSIFIED SECTION

The following reactions have been identified during postmarketing use of XALATAN in clinical practice. Because they are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to XALATAN, or a combination of these factors, include:

Nervous System Disorders: Dizziness; headache; toxic epidermal necrolysis

Eye Disorders: Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes); keratitis; corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; trichiasis; periorbital and lid changes resulting in deepening of the eyelid sulcus; iris cyst; eyelid skin darkening; localized skin reaction on the eyelids; conjunctivitis; pseudopemphigoid of the ocular conjunctiva.

Respiratory, Thoracic and Mediastinal Disorders: Asthma and exacerbation of asthma; dyspnea

Gastrointestinal Disorders: Nausea; vomiting

Skin and Subcutaneous Tissue Disorders: Pruritis

Infections and Infestations: Herpes keratitis

Cardiac Disorders: Angina; palpitations; angina unstable

General Disorders and Administration Site Conditions: Chest pain

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

8.1 Pregnancy

PREGNANCY SECTION

Risk Summary

RISKS

There are no adequate and well-controlled studies of XALATAN administration in pregnant women.to inform drug-associated risks.

In animal reproduction studies, intravenous (IV) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see Data].

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies.

Data

SPL UNCLASSIFIED SECTION

Animal Data

SPL UNCLASSIFIED SECTION

Embryofetal studies were conducted in pregnant rabbits administered latanoprost daily by IV injection on gestation days 6 through 18, to target the period of organogenesis. A no observed adverse effect level (NOAEL) was not established for rabbit developmental toxicity. Post-implantation loss due to late resorption was shown as doses ≥0.2 mcg/kg/day (equivalent to 1.3 times the maximum recommended human ophthalmic dose [RHOD], on a mg/m² basis, assuming 100% absorption). Spina bifida and abortion occurred at 5 mcg/kg/day (equivalent to 32 times the maximum RHOD). Total litter loss due to early resorption was observed at doses ≥50 mcg/kg/day (324 times the maximum RHOD). Transient signs of maternal toxicity were observed after IV dosing (increased breathing, muscle tremors, slight motor incoordination) at 300 mcg/kg/day (1946 times the maximum RHOD). No maternal toxicity was observed at doses up to 50 mcg/kg/day.

Embryofetal studies were conducted in pregnant rats administered latanoprost daily by IV injection on gestation days 6 through 15, to target the period of organogenesis. A NOAEL for rat developmental toxicity was not established. Cleft palate was observed at 1 mcg/kg (equivalent to 3.2 times the maximum RHOD, on a mg/m2 basis, assuming 100% absorption). Brain porencephalic cyst(s) were observed ≥50 mcg/kg (162 times the maximum RHOD). Skeletal anomalies were observed at 250 mcg/kg (811 times the maximum RHOD). No maternal toxicity was detectable at 250 mcg/kg/day.

Prenatal and postnatal development was assessed in rats. Pregnant rats were administered latanoprost daily by IV injection from gestation day 15, through delivery, until weaning (lactation Day 21). No adverse effects on rat offspring were observed at doses up to 10 mcg/kg/day (32 times the maximum RHOD, on a mg/m² basis, assuming 100% absorption). At 100 mcg/kg/day (324 times the maximum RHOD), maternal deaths and pup mortality occurred.

8.2 Lactation

LACTATION SECTION

Risk Summary

RISKS

It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when XALATAN is administered to a nursing woman.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XALATAN and any potential adverse effects on the breastfed child from XALATAN.

8.4 Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

GERIATRIC USE SECTION

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

10 OVERDOSAGE

OVERDOSAGE SECTION

IV infusion of up to 3 mcg/kg of latanoprost in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment with XALATAN and no adverse reactions were observed. IV dosages of 5.5 to 10 mcg/kg caused abdominal pain, dizziness, fatigue, hot flushes, nausea, and sweating.

If overdosage with XALATAN occurs, treatment should be symptomatic.

11 DESCRIPTION

DESCRIPTION SECTION

Latanoprost is a prostaglandin F_2α analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C₂₆H₄₀O₅ and its chemical structure is:

Latanoprost is a colorless to slightly yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol, and octanol. It is practically insoluble in water.

XALATAN (latanoprost ophthalmic solution) 0.005% is supplied as a sterile, isotonic, buffered aqueous solution of latanoprost with a pH of approximately 6.7 and an osmolality of approximately 267 mOsmol/kg. Each mL of XALATAN contains 50 mcg of latanoprost. Benzalkonium chloride, 0.02% is added as a preservative. The inactive ingredients are: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, and water for injection. One drop contains approximately 1.5 mcg of latanoprost.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

Latanoprost is a prostaglandin F_2α analogue that is believed to reduce the IOP by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

12.2 Pharmacodynamics

PHARMACODYNAMICS SECTION

Reduction of the IOP in man starts about 3-4 hours after administration and maximum effect is reached after 8-12 hours. IOP reduction is present for at least 24 hours.

12.3 Pharmacokinetics

PHARMACOKINETICS SECTION

Absorption

SPL UNCLASSIFIED SECTION

Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active.

Distribution

SPL UNCLASSIFIED SECTION

The distribution volume in humans is 0.16 ± 0.02 L/kg. The acid of latanoprost can be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after local administration. Studies in man indicate that the peak concentration in the aqueous humor is reached about two hours after topical administration.

Elimination

SPL UNCLASSIFIED SECTION

Metabolism

SPL UNCLASSIFIED SECTION

Latanoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to the biologically active acid. The active acid of latanoprost reaching the systemic circulation is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid β-oxidation.

Excretion

SPL UNCLASSIFIED SECTION

The elimination of the acid of latanoprost from human plasma is rapid (t_1/2 = 17 min) after both IV and topical administration. Systemic clearance is approximately 7 mL/min/kg. Following hepatic β-oxidation, the metabolites are mainly eliminated via the kidneys. Approximately 88% and 98% of the administered dose are recovered in the urine after topical and IV dosing, respectively.

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Carcinogenesis

Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 170 mcg/kg/day (approximately 2800 times the recommended maximum human dose) for up to 20 and 24 months, respectively.

Mutagenesis

Latanoprost was not mutagenic in bacteria, in mouse lymphoma, or in mouse micronucleus tests. Chromosome aberrations were observed in vitro with human lymphocytes. Additional in vitro and in vivo studies on unscheduled DNA synthesis in rats were negative.

Impairment of Fertility

Latanoprost has not been found to have any effect on male or female fertility in rat studies at IV doses up to 250 mcg/kg/day (811 times the maximum RHOD, on a mg/m² basis, assuming 100% absorption).

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

14.1 Elevated Baseline IOP

SPL UNCLASSIFIED SECTION

Patients with mean baseline IOP of 24 – 25 mmHg who were treated for 6 months in multi-center, randomized, controlled trials demonstrated 6 – 8 mmHg reductions in IOP. This IOP reduction with XALATAN 0.005% dosed once daily was equivalent to the effect of timolol 0.5% dosed twice daily.

14.2 Progression of Increased Iris Pigmentation

SPL UNCLASSIFIED SECTION

A 3-year open-label, prospective safety study with a 2-year extension phase was conducted to evaluate the progression of increased iris pigmentation with continuous use of XALATAN once-daily as adjunctive therapy in 519 patients with open-angle glaucoma. The analysis was based on observed-cases population of the 380 patients who continued in the extension phase.

Results showed that the onset of noticeable increased iris pigmentation occurred within the first year of treatment for the majority of the patients who developed noticeable increased iris pigmentation. Patients continued to show signs of increasing iris pigmentation throughout the 5 years of the study. Observation of increased iris pigmentation did not affect the incidence, nature, or severity of adverse events (other than increased iris pigmentation) recorded in the study. IOP reduction was similar regardless of the development of increased iris pigmentation during the study.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

2.5 mL fill, 50 mcg/mL (0.005%): Package of 1 bottle: NDC 0013-8303-04

Storage: Protect from light. Store unopened bottle(s) under refrigeration at 2°C to 8°C (36°F to 46°F). During shipment to the patient, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 8 days. Once a bottle is opened for use, it may be stored at room temperature up to 25°C (77°F) for 6 weeks.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Potential for Pigmentation

Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of XALATAN [see Warnings and Precautions (5.1)].

Potential for Eyelash Changes

Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with XALATAN. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.

Handling the Container

Instruct patients to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions (5.6)].

When to Seek Physician Advice

Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of the multiple-dose container.

Contact Lens Use

Advise patients that XALATAN contains benzalkonium chloride, which may be absorbed by contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of XALATAN.

Use with Other Ophthalmic Drugs

Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

If a Dose is Missed

Advise patients that if one dose is missed, treatment should continue with the next dose as normal.

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Pfizer Manufacturing Belgium NV
Puurs, Belgium

LAB-0135-14.1

PRINCIPAL DISPLAY PANEL - 2.5 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0013-8303-04

Pfizer

Xalatan^®

latanoprost ophthalmic solution

STERILE
0.005%

125 mcg/2.5 mL*

One 2.5 mL Bottle Rx only

Store unopened bottle
under refrigeration at
2°C to 8°C (36°F to 45°F).

Opened bottle may be
stored at room temperature
up to 25°C (77°F) for
6 weeks.

PROTECT FROM LIGHT

Keep out of reach of children.

Not Child Resistant

DOSAGE AND USE

Usual doeage: 1 drop in the
affected eye(s) in the evening.

* Each mL contains:
latanoprost, 50 micorgrams:
benzalkonium chloride,
0.2 mg; sodium chloride,
sodium dihydrogen
phosphate, disodium
hydrogen phosphate.

Important information for
Mail-Order Patients:
Contact dispensing pharmacy
if prescription is not received
within 8 days of dispensing date.
SEE DATE ON PRESCRIPTION
LABEL

During shipment to the patient,
the bottle may be maintained at
temperatures up to 40°C (104°F)
for a period not exceeding 8 days.

Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 2.5 mL Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8d59b88b-5059-46d6-8e48-d5d9371caa10	Product name	2	20260211
f6b0b05b-3bf2-088a-8ccc-e1cf01a91e86	Product name	4	20250729
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
de829a7d-0b51-4e4d-a051-6a6568f15688	Product name	1	20230919
203382e3-d801-4f70-866f-ebe316583560	Product name	1	20190624
e516be5e-351f-4b2e-a26b-fdff13181605	Product name	1	20181220
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0013-8303	XALATAN (LATANOPROST) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	25	Legacy NDC	20241025_f4e73059-5ba0-4d73-9ea1-09d8d654e844.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0013-8303-01	ML - Milliliter	0013-8303	e0501419-ec7b-42c1-bf83-f1b3acf79e6b	1	2012-07-24
0013-8303-04	ML - Milliliter	0013-8303	0ff032f9-bad2-4ec5-ba4e-9ce4d972610a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LATANOPROST	ACTIVE INGREDIENT	6Z5B6HVF6O	12
LATANOPROST	ACTIVE MOIETY	6Z5B6HVF6O	12
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	12
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	12
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Xalatan
latanoprost
LATANOPROST ACID
BENZALKONIUM CHLORIDE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0013-8303	0013-8303-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LATANOPROST	6Z5B6HVF6O	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 206 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SUSPENSION / ORAL		66 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / INTRAVENOUS		381 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	LIQUID / INTRAVENOUS		381 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SOLUTION / INTRAVENOUS		2460 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVITREAL	10 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	OINTMENT / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1800 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / OPHTHALMIC	1.21 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / TOPICAL	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / RETROBULBAR		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRAVENOUS		381 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / NASAL	5 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	LOZENGE / TRANSMUCOSAL		112 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ENDOTRACHEAL	46.76 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / IONTOPHORESIS	0.6 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		24 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / SOFT TISSUE		3 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRAMUSCULAR		1751 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBMUCOSAL	16 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVASCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET, EXTENDED RELEASE / ORAL		210 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRATYMPANIC		2 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, DENTIFRICE / DENTAL	0.03 mg/mg		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRALESIONAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SOLUTION / INTRATHECAL		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ORAL		98 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET / ORAL		96 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE, EXTENDED RELEASE / ORAL		207 mg	Exact identifier — unii candidate 48 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020597-001	XALATAN	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020597-001	AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N020597-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020597-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020597-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020597-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020597-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020597-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020597-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020597-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020597-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020597-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020597-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020597-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020597-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020597-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020597-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020597-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020597-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020597-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020597-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020597-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020597-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020597-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020597-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020597-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020597-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020597-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020597-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020597-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020597-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020597-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020597-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020597-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020597-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020597-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020597-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020597-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020597-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020597-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020597-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020597-001	AT	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4fa79418-60f3-45db-9cce-8a073d3436c5			f4e73059-5ba0-4d73-9ea1-09d8d654e844	2022-12-27	Warnings, Adverse reactions	Exact identifier spl id: 4fa79418-60f3-45db-9cce-8a073d3436c5 spl set id: f4e73059-5ba0-4d73-9ea1-09d8d654e844

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.