NDC 68258-8976

Xalatan

Latanoprost

Xalatan is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Latanoprost.

Product ID68258-8976_309e27fc-3503-4307-880c-2d9492423870
NDC68258-8976
Product TypeHuman Prescription Drug
Proprietary NameXalatan
Generic NameLatanoprost
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date1995-03-20
Marketing CategoryNDA / NDA
Application NumberNDA020597
Labeler NameDispensing Solutions, Inc.
Substance NameLATANOPROST
Active Ingredient Strength50 ug/mL
Pharm ClassesProstaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68258-8976-2

2.5 mL in 1 BOTTLE, DROPPER (68258-8976-2)
Marketing Start Date1995-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68258-8976-2 [68258897602]

Xalatan SOLUTION
Marketing CategoryNDA
Application NumberNDA020597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1995-03-20
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
LATANOPROST50 ug/mL

OpenFDA Data

SPL SET ID:0f4881ec-2984-4853-bc25-5b14c3b79da7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 542527
  • 314072
    • PHarm Class EPC
  • Prostaglandin Analog [EPC]
    • 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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