NDC 55700-383

MOVANTIK

Naloxegol Oxalate

MOVANTIK is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Quality Care Products, Llc. The primary component is Naloxegol Oxalate.

Product ID55700-383_df64082c-a5c5-4d74-adc5-065cf9b0b061
NDC55700-383
Product TypeHuman Prescription Drug
Proprietary NameMOVANTIK
Generic NameNaloxegol Oxalate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-03-06
Marketing CategoryNDA / NDA
Application NumberNDA204760
Labeler NameQuality Care Products, LLC
Substance NameNALOXEGOL OXALATE
Active Ingredient Strength25 mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 55700-383-30

30 TABLET, FILM COATED in 1 BOTTLE (55700-383-30)
Marketing Start Date2016-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-383-30 [55700038330]

MOVANTIK TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204760
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-26

Drug Details

Active Ingredients

IngredientStrength
NALOXEGOL OXALATE25 mg/1

OpenFDA Data

SPL SET ID:5c02665d-05d2-4e99-b403-c270de543ebe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1601373
  • 1551782
  • Pharmacological Class

    • Opioid Antagonist [EPC]
    • Opioid Antagonists [MoA]

    NDC Crossover Matching brand name "MOVANTIK" or generic name "Naloxegol Oxalate"

    NDCBrand NameGeneric Name
    0310-1969MOVANTIKnaloxegol oxalate
    0310-1970MOVANTIKnaloxegol oxalate
    55700-383MOVANTIKnaloxegol oxalate
    55700-988MOVANTIKnaloxegol oxalate
    57841-1300MOVANTIKnaloxegol oxalate
    57841-1301MOVANTIKnaloxegol oxalate

    Trademark Results [MOVANTIK]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MOVANTIK
    MOVANTIK
    86205691 4782846 Live/Registered
    AstraZeneca AB
    2014-02-27
    MOVANTIK
    MOVANTIK
    86089235 4600146 Live/Registered
    AstraZeneca AB
    2013-10-11

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