NDC 0078-0457

Trileptal

Oxcarbazepine

Trileptal is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Oxcarbazepine.

• Product ID: 0078-0457_17f72463-652b-413b-855f-802851310051
• NDC: 0078-0457
• Product Type: Human Prescription Drug
• Proprietary Name: Trileptal
• Generic Name: Oxcarbazepine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2000-01-30
• Marketing Category: NDA / NDA
• Application Number: NDA021014
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: OXCARBAZEPINE
• Active Ingredient Strength: 600 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0457-05

100 TABLET, FILM COATED in 1 BOTTLE (0078-0457-05)

• Marketing Start Date: 2000-01-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0457-05 [00078045705]

Trileptal TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021014
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-01-30

NDC 0078-0457-61 [00078045761]

Trileptal TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021014
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-03-18

NDC 0078-0457-35 [00078045735]

Trileptal TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021014
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-01-30

Drug Details

Active Ingredients

Ingredient	Strength
OXCARBAZEPINE	600 mg/1

OpenFDA Data

• SPL SET ID: 4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • VZI5B1W380
• RxNorm Concept Unique ID - RxCUI:
  • 312137
  • 312138
  • 312136
  • 283536
  • 261356
  • 261360
  • 351992
  • 262090

Pharmacological Class

• Anti-epileptic Agent [EPC]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]
• Anti-epileptic Agent [EPC]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]

NDC Crossover Matching brand name "Trileptal" or generic name "Oxcarbazepine"

NDC	Brand Name	Generic Name
0078-0337	Trileptal	oxcarbazepine
0078-0357	Trileptal	oxcarbazepine
0078-0456	Trileptal	oxcarbazepine
0078-0457	Trileptal	oxcarbazepine
70518-1300	Trileptal	Trileptal
70518-1349	Trileptal	Trileptal
55289-007	Trileptal	Trileptal
61919-569	TRILEPTAL	TRILEPTAL
0054-0097	Oxcarbazepine	Oxcarbazepine
0054-0098	Oxcarbazepine	Oxcarbazepine
0054-0099	Oxcarbazepine	Oxcarbazepine
0054-0199	Oxcarbazepine	Oxcarbazepine
0615-6593	Oxcarbazepine	Oxcarbazepine
0615-6594	Oxcarbazepine	Oxcarbazepine
0615-6595	Oxcarbazepine	Oxcarbazepine
0615-8153	Oxcarbazepine	Oxcarbazepine