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NDC 50268-0649-12 Oxcarbazepine 300 mg/5mL Details

Oxcarbazepine 300 mg/5mL

Oxcarbazepine is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvPAK. The primary component is OXCARBAZEPINE.

MedlinePlus Drug Summary

Oxcarbazepine (Trileptal) is used alone or in combination with other medications to control certain types of seizures in adults and children. Oxcarbazepine extended-release tablets (Oxtellar XR) are used in combination with other medications to control certain types of seizures in adults and children 6 years of age and older. Oxcarbazepine is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Related Packages: 50268-0649-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxcarbazepine

Product Information

NDC	50268-0649
Product ID	50268-649_f8acf91d-57f3-3c4f-e053-6294a90acc21
Associated GPIs	72600046001820
GCN Sequence Number	033724
GCN Sequence Number Description	oxcarbazepine ORAL SUSP 300 MG/5ML ORAL
HIC3	H4B
HIC3 Description	ANTICONVULSANTS
GCN	21723
HICL Sequence Number	011735
HICL Sequence Number Description	OXCARBAZEPINE
Brand/Generic	Generic
Proprietary Name	Oxcarbazepine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Oxcarbazepine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	300
Active Ingredient Units	mg/5mL
Substance Name	OXCARBAZEPINE
Labeler Name	AvPAK
Pharmaceutical Class	Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA202961
Listing Certified Through	2024-12-31

Package

NDC 50268-0649-12 (50268064912)

Pricing Information	N/A
NDC Package Code	50268-649-12
Billing NDC	50268064912
Package	20 CUP, UNIT-DOSE in 1 BOX (50268-649-12) / 5 mL in 1 CUP, UNIT-DOSE (50268-649-11)
Marketing Start Date	2021-06-14
NDC Exclude Flag	N