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NDC 73336-0075-07 GEMTESA 75 mg/1 Details

GEMTESA 75 mg/1

GEMTESA is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sumitomo Pharma America, Inc.. The primary component is VIBEGRON.

MedlinePlus Drug Summary

Vibegron is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in adults. Vibegron is in a class of medications called beta-3 adrenergic agonists. It works by relaxing the bladder muscles to increase bladder capacity.

Related Packages: 73336-0075-07
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Vibegron

Product Information

NDC	73336-0075
Product ID	73336-075_dff76a29-8827-4ba4-8ee8-27921744748a
Associated GPIs	54200080000320
GCN Sequence Number	081787
GCN Sequence Number Description	vibegron TABLET 75 MG ORAL
HIC3	R1V
HIC3 Description	OVERACTIVE BLADDER AGENTS, BETA-3 ADRENERGIC RECEP
GCN	49009
HICL Sequence Number	047040
HICL Sequence Number Description	VIBEGRON
Brand/Generic	Brand
Proprietary Name	GEMTESA
Proprietary Name Suffix	n/a
Non-Proprietary Name	vibegron
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	75
Active Ingredient Units	mg/1
Substance Name	VIBEGRON
Labeler Name	Sumitomo Pharma America, Inc.
Pharmaceutical Class	Adrenergic beta3-Agonists [MoA], beta3-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA213006
Listing Certified Through	2025-12-31

Package

NDC 73336-0075-07 (73336007507)

Pricing Information	N/A
NDC Package Code	73336-075-07
Billing NDC	73336007507
Package	1 BOTTLE in 1 CARTON (73336-075-07) / 7 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2020-12-29
NDC Exclude Flag	N