NDC 0013-8303

Xalatan

Latanoprost

Xalatan is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Latanoprost.

• Product ID: 0013-8303_4dadca35-efc9-4c04-81c0-37fe44653b56
• NDC: 0013-8303
• Product Type: Human Prescription Drug
• Proprietary Name: Xalatan
• Generic Name: Latanoprost
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 1995-03-20
• Marketing Category: NDA / NDA
• Application Number: NDA020597
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: LATANOPROST
• Active Ingredient Strength: 50 ug/mL
• Pharm Classes: Prostaglandin Analog [EPC], Prostaglandins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0013-8303-04

1 BOTTLE, DROPPER in 1 CARTON (0013-8303-04) > 2.5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 1995-03-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0013-8303-01 [00013830301]

Xalatan SOLUTION

• Marketing Category: NDA
• Application Number: NDA020597
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1995-03-20
• Marketing End Date: 2015-03-31

NDC 0013-8303-98 [00013830398]

Xalatan SOLUTION

• Marketing Category: NDA
• Application Number: NDA020597
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-06-30
• Marketing End Date: 2011-10-04

NDC 0013-8303-04 [00013830304]

Xalatan SOLUTION

• Marketing Category: NDA
• Application Number: NDA020597
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1995-03-20

Drug Details

Active Ingredients

Ingredient	Strength
LATANOPROST	50 ug/mL

OpenFDA Data

• SPL SET ID: f4e73059-5ba0-4d73-9ea1-09d8d654e844
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • 6Z5B6HVF6O
• RxNorm Concept Unique ID - RxCUI:
  • 542527
  • 314072
• PHarm Class EPC:
  • Prostaglandin Analog [EPC]
• UPC Code:
  • 0300138303043
• NUI Code:
  • N0000175454
  • N0000007706

Pharmacological Class

• Prostaglandin Analog [EPC]
• Prostaglandins [Chemical/Ingredient]

NDC Crossover Matching brand name "Xalatan" or generic name "Latanoprost"

NDC	Brand Name	Generic Name
0013-8303	Xalatan	latanoprost
68258-8976	Xalatan	Xalatan
0517-0830	Latanoprost	Latanoprost
13985-610	Latanoprost	Latanoprost
17478-625	LATANOPROST	LATANOPROST
21695-986	Latanoprost	Latanoprost
24208-463	Latanoprost	latanoprost
50090-1240	LATANOPROST	LATANOPROST
50090-1920	Latanoprost	latanoprost
55545-1010	LATANOPROST	latanoprost
59762-0333	Latanoprost	Latanoprost
61314-547	Latanoprost	Latanoprost
61919-112	LATANOPROST	LATANOPROST
64980-516	LATANOPROST	latanoprost
65862-872	Latanoprost	Latanoprost
47335-317	XELPROS	latanoprost