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 ID0013-8303_4dadca35-efc9-4c04-81c0-37fe44653b56
NDC0013-8303
Product TypeHuman Prescription Drug
Proprietary NameXalatan
Generic NameLatanoprost
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date1995-03-20
Marketing CategoryNDA / NDA
Application NumberNDA020597
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameLATANOPROST
Active Ingredient Strength50 ug/mL
Pharm ClassesProstaglandin Analog [EPC], Prostaglandins [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0013-8303-04

1 BOTTLE, DROPPER in 1 CARTON (0013-8303-04) > 2.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date1995-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0013-8303-01 [00013830301]

Xalatan SOLUTION
Marketing CategoryNDA
Application NumberNDA020597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1995-03-20
Marketing End Date2015-03-31

NDC 0013-8303-98 [00013830398]

Xalatan SOLUTION
Marketing CategoryNDA
Application NumberNDA020597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-30
Marketing End Date2011-10-04

NDC 0013-8303-04 [00013830304]

Xalatan SOLUTION
Marketing CategoryNDA
Application NumberNDA020597
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1995-03-20

Drug Details

Active Ingredients

IngredientStrength
LATANOPROST50 ug/mL

OpenFDA Data

SPL SET ID:f4e73059-5ba0-4d73-9ea1-09d8d654e844
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0013-8303Xalatanlatanoprost
    68258-8976XalatanXalatan
    0517-0830LatanoprostLatanoprost
    13985-610LatanoprostLatanoprost
    17478-625LATANOPROSTLATANOPROST
    21695-986LatanoprostLatanoprost
    24208-463Latanoprostlatanoprost
    50090-1240LATANOPROSTLATANOPROST
    50090-1920Latanoprostlatanoprost
    55545-1010LATANOPROSTlatanoprost
    59762-0333LatanoprostLatanoprost
    61314-547LatanoprostLatanoprost
    61919-112LATANOPROSTLATANOPROST
    64980-516LATANOPROSTlatanoprost
    65862-872LatanoprostLatanoprost
    47335-317XELPROSlatanoprost

    Trademark Results [Xalatan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XALATAN
    XALATAN
    74498623 2118188 Live/Registered
    PFIZER HEALTH AB
    1994-03-09

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