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NDC 73289-0002-00 VIGADRONE 50 mg/mL Details

VIGADRONE 50 mg/mL

VIGADRONE is a ORAL POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aucta Pharmaceuticals, Inc.. The primary component is VIGABATRIN.

MedlinePlus Drug Summary

Vigabatrin tablets are used in combination with other medications to control certain types of seizures in adults and children 10 years of age or older whose seizures were not controlled by several other medications. Vigabatrin powder is used to control infantile spasms (a type of seizure that babies and children can have) in babies 1 month to 2 years of age. Vigabatrin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Related Packages: 73289-0002-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Vigabatrin

Product Information

NDC	73289-0002
Product ID	73289-0002_edae8af2-402e-0afd-e053-2995a90aded1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	VIGADRONE
Proprietary Name Suffix	n/a
Non-Proprietary Name	vigabatrin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	POWDER, FOR SOLUTION
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/mL
Substance Name	VIGABATRIN
Labeler Name	Aucta Pharmaceuticals, Inc.
Pharmaceutical Class	Anti-epileptic Agent [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210196
Listing Certified Through	2023-12-31

Package

NDC 73289-0002-00 (73289000200)

Pricing Information	N/A
NDC Package Code	73289-0002-0
Billing NDC	73289000200
Package	50 PACKAGE in 1 CARTON (73289-0002-0) / 10 mL in 1 PACKAGE
Marketing Start Date	2018-06-21
NDC Exclude Flag	N