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 TABLET, FILM COATED
Routes
ORAL
Active Ingredients

oxcarbazepine 150 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0456
Product ID 0078-0456_dcd739ce-e938-40e6-8912-ca4f34b49cf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021014
Listing Expiration 2026-12-31
Marketing Start 2000-01-30

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 00780456
Hyphenated Format 0078-0456

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 NDA021014 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0078-0456-05)
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0456-35) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0456-61)
source: ndc

Packages (2)

0078-0456-05 100 TABLET, FILM COATED in 1 BOTTLE (0078-0456-05) 0078-0456-35 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0456-35) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0456-61)

Ingredients (1)

oxcarbazepine (150 mg/1)

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": "100 TABLET, FILM COATED in 1 BOTTLE (0078-0456-05)", "package_ndc": "0078-0456-05", "marketing_start_date": "20000130"}, {"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0456-35)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0456-61)", "package_ndc": "0078-0456-35", "marketing_start_date": "20000130"}], "brand_name": "Trileptal", "product_id": "0078-0456_dcd739ce-e938-40e6-8912-ca4f34b49cf3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0078-0456", "generic_name": "oxcarbazepine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trileptal", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "150 mg/1"}], "application_number": "NDA021014", "marketing_category": "NDA", "marketing_start_date": "20000130", "listing_expiration_date": "20261231"}