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NDC 00054-0199-59 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 Hikma Pharmaceuticals USA Inc.. 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: 00054-0199-59
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxcarbazepine

Product Information

NDC	00054-0199
Product ID	0054-0199_84e5c5d4-55ab-4bbe-9d32-de0f65f3aedd
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	Hikma Pharmaceuticals USA Inc.
Pharmaceutical Class	Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA201193
Listing Certified Through	2024-12-31

Package

NDC 00054-0199-59 (00054019959)

Pricing Information	N/A
NDC Package Code	0054-0199-59
Billing NDC	00054019959
Package	250 mL in 1 BOTTLE (0054-0199-59)
Marketing Start Date	2012-10-03
NDC Exclude Flag	N