Search by Drug Name or NDC

NDC 00245-6001-11 VIGADRONE 500 mg/1 Details

VIGADRONE 500 mg/1

VIGADRONE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Upsher-Smith Laboratories, LLC. 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: 00245-6001-11
Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Vigabatrin

Product Information

NDC	00245-6001
Product ID	0245-6001_dfc2fa77-36d4-41d8-a5e5-4881a91a8497
Associated GPIs
GCN Sequence Number	017870
GCN Sequence Number Description	vigabatrin TABLET 500 MG ORAL
HIC3	H4B
HIC3 Description	ANTICONVULSANTS
GCN	64315
HICL Sequence Number	007377
HICL Sequence Number Description	VIGABATRIN
Brand/Generic	Generic
Proprietary Name	VIGADRONE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Vigabatrin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	VIGABATRIN
Labeler Name	Upsher-Smith Laboratories, LLC
Pharmaceutical Class	Anti-epileptic Agent [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA214749
Listing Certified Through	2024-12-31

Package

NDC 00245-6001-11 (00245600111)

Pricing Information	N/A
NDC Package Code	0245-6001-11
Billing NDC	00245600111
Package	1 BOTTLE in 1 CARTON (0245-6001-11) / 100 TABLET in 1 BOTTLE
Marketing Start Date	2023-06-30
NDC Exclude Flag	N