NDC 55289-007

Trileptal

Oxcarbazepine

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

• Product ID: 55289-007_84b528ab-23fa-e42c-e053-2991aa0acc4d
• NDC: 55289-007
• 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: PD-Rx Pharmaceuticals, Inc.
• Substance Name: OXCARBAZEPINE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55289-007-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-007-30)

• Marketing Start Date: 2011-03-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-007-30 [55289000730]

Trileptal TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021014
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-03-17

Drug Details

Active Ingredients

Ingredient	Strength
OXCARBAZEPINE	300 mg/1

OpenFDA Data

• SPL SET ID: e61cfb01-55fc-42d5-8d9a-25d73f905e04
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • VZI5B1W380
• RxNorm Concept Unique ID - RxCUI:
  • 312137
  • 261360
• UPC Code:
  • 0355289007302

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