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NDC 57841-1300-03 MOVANTIK 12.5 mg/1 Details

MOVANTIK 12.5 mg/1

MOVANTIK is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RedHill Biopharma Ltd. The primary component is NALOXEGOL OXALATE.

MedlinePlus Drug Summary

Naloxegol is used to treat constipation caused by opiate (narcotic) pain medications in adults with chronic (ongoing) pain that is not caused by cancer. Naloxegol is in a class of medications called peripherally acting mu-opioid receptor antagonists. It works by protecting the bowel from the effects of opiate (narcotic) medications.

Related Packages: 57841-1300-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naloxegol

Product Information

NDC	57841-1300
Product ID	57841-1300_3da484be-32a1-4265-b58e-fa55b7acd59a
Associated GPIs	52580060300320
GCN Sequence Number	073335
GCN Sequence Number Description	naloxegol oxalate TABLET 12.5 MG ORAL
HIC3	H3Y
HIC3 Description	MU-OPIOID RECEPTOR ANTAGONISTS,PERIPHERALLY-ACTING
GCN	37725
HICL Sequence Number	041686
HICL Sequence Number Description	NALOXEGOL OXALATE
Brand/Generic	Brand
Proprietary Name	MOVANTIK
Proprietary Name Suffix	n/a
Non-Proprietary Name	naloxegol oxalate
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/1
Substance Name	NALOXEGOL OXALATE
Labeler Name	RedHill Biopharma Ltd
Pharmaceutical Class	Opioid Antagonist [EPC], Opioid Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA204760
Listing Certified Through	2024-12-31

Package

NDC 57841-1300-03 (57841130003)

Pricing Information	N/A
NDC Package Code	57841-1300-3
Billing NDC	57841130003
Package	10 BLISTER PACK in 1 CARTON (57841-1300-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2020-10-01
NDC Exclude Flag	N