NDC 0310-1969

MOVANTIK

Naloxegol Oxalate

MOVANTIK is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Naloxegol Oxalate.

Product ID0310-1969_5f112925-e955-4d74-98a3-0d9ae237a73a
NDC0310-1969
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 NameAstraZeneca Pharmaceuticals LP
Substance NameNALOXEGOL OXALATE
Active Ingredient Strength13 mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0310-1969-30

30 TABLET, FILM COATED in 1 BOTTLE (0310-1969-30)
Marketing Start Date2015-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-1969-90 [00310196990]

MOVANTIK TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-06

NDC 0310-1969-95 [00310196995]

MOVANTIK TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-01

NDC 0310-1969-39 [00310196939]

MOVANTIK TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204760
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-06

NDC 0310-1969-30 [00310196930]

MOVANTIK TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204760
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-06

Drug Details

Active Ingredients

IngredientStrength
NALOXEGOL OXALATE12.5 mg/1

OpenFDA Data

SPL SET ID:f49c6978-ca7b-4a66-919b-757f8f92ef64
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1551917
  • 1551923
  • 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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