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NDC 59385-0041-07 SYMPROIC 0.2 mg/1 Details

SYMPROIC 0.2 mg/1

SYMPROIC is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BioDelivery Sciences International Inc. The primary component is NALDEMEDINE TOSYLATE.

MedlinePlus Drug Summary

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

Related Packages: 59385-0041-07
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Naldemedine

Product Information

NDC	59385-0041
Product ID	59385-041_e28338cb-0ff5-4938-a82f-0d855ad3b587
Associated GPIs	52580057200320
GCN Sequence Number	077258
GCN Sequence Number Description	naldemedine tosylate TABLET 0.2 MG ORAL
HIC3	H3Y
HIC3 Description	MU-OPIOID RECEPTOR ANTAGONISTS,PERIPHERALLY-ACTING
GCN	43216
HICL Sequence Number	044176
HICL Sequence Number Description	NALDEMEDINE TOSYLATE
Brand/Generic	Brand
Proprietary Name	SYMPROIC
Proprietary Name Suffix	n/a
Non-Proprietary Name	naldemedine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	0.2
Active Ingredient Units	mg/1
Substance Name	NALDEMEDINE TOSYLATE
Labeler Name	BioDelivery Sciences International Inc
Pharmaceutical Class	Opioid Antagonist [EPC], Opioid Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA208854
Listing Certified Through	2024-12-31

Package

NDC 59385-0041-07 (59385004107)

Pricing Information	N/A
NDC Package Code	59385-041-07
Billing NDC	59385004107
Package	1 BLISTER PACK in 1 CARTON (59385-041-07) / 7 TABLET in 1 BLISTER PACK
Marketing Start Date	2020-07-01
NDC Exclude Flag	N