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NDC 71428-0007-25 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 Glasshouse Pharmaceuticals Limited Canada. 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: 71428-0007-25
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Oxcarbazepine

Product Information

NDC	71428-0007
Product ID	71428-007_dd3f07c0-8d23-40aa-e053-2995a90afafe
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	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	Glasshouse Pharmaceuticals Limited Canada
Pharmaceutical Class	Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA212428
Listing Certified Through	2023-12-31

Package

NDC 71428-0007-25 (71428000725)

Pricing Information	N/A
NDC Package Code	71428-007-25
Billing NDC	71428000725
Package	1 BOTTLE in 1 CARTON (71428-007-25) / 250 mL in 1 BOTTLE
Marketing Start Date	2021-09-21
NDC Exclude Flag	N