trileptal

Generic: oxcarbazepine

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name trileptal
Generic Name oxcarbazepine
Labeler novartis pharmaceuticals corporation
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 60 mg/mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0357
Product ID 0078-0357_dcd739ce-e938-40e6-8912-ca4f34b49cf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021285
Listing Expiration 2026-12-31
Marketing Start 2001-05-30

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780357
Hyphenated Format 0078-0357

Supplemental Identifiers

RxCUI
261356 261360 262090 283536 312136 312137 312138 351992
UNII
VZI5B1W380
NUI
N0000175753 N0000008486

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name trileptal (source: ndc)
Generic Name oxcarbazepine (source: ndc)
Application Number NDA021285 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 250 mL in 1 BOTTLE (0078-0357-52)
source: ndc

Packages (1)

0078-0357-52 250 mL in 1 BOTTLE (0078-0357-52)

Ingredients (1)

oxcarbazepine (60 mg/mL)

Linked Drug Pages (1)

Trileptal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dcd739ce-e938-40e6-8912-ca4f34b49cf3", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["261356", "261360", "262090", "283536", "312136", "312137", "312138", "351992"], "spl_set_id": ["4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 mL in 1 BOTTLE (0078-0357-52)", "package_ndc": "0078-0357-52", "marketing_start_date": "20010530"}], "brand_name": "Trileptal", "product_id": "0078-0357_dcd739ce-e938-40e6-8912-ca4f34b49cf3", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0078-0357", "generic_name": "oxcarbazepine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trileptal", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "60 mg/mL"}], "application_number": "NDA021285", "marketing_category": "NDA", "marketing_start_date": "20010530", "listing_expiration_date": "20261231"}