NDC 55545-1010

LATANOPROST

Latanoprost

LATANOPROST is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Fdc Limited. The primary component is Latanoprost.

Product ID55545-1010_987a5fd5-0afd-1d4e-e053-2a95a90a5d1d
NDC55545-1010
Product TypeHuman Prescription Drug
Proprietary NameLATANOPROST
Generic NameLatanoprost
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2016-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA202442
Labeler NameFDC Limited
Substance NameLATANOPROST
Active Ingredient Strength50 ug/mL
Pharm ClassesProstaglandin Analog [EPC],Prostaglandins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55545-1010-1

1 BOTTLE, DROPPER in 1 CARTON (55545-1010-1) > 2.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2016-09-01
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
LATANOPROST50 ug/mL

OpenFDA Data

SPL SET ID:891a5db6-ca9b-48f0-b3c6-7cd56e310c5a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314072
  • PHarm Class EPC
  • Prostaglandin Analog [EPC]
  • NUI Code
  • N0000175454
  • N0000007706
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68071-1683LatanoprostLatanoprost
    68071-4650LatanoprostLatanoprost
    68071-4612LatanoprostLatanoprost
    71205-154LatanoprostLatanoprost
    68071-4893LATANOPROSTLATANOPROST
    70069-421LATANOPROSTLATANOPROST
    0013-8303Xalatanlatanoprost
    47335-317XELPROSlatanoprost

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