oxcarbazepine

Generic: oxcarbazepine

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

oxcarbazepine 150 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-220
Product ID 62559-220_00918074-5761-4530-bb20-5cbf3efb84e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078005
Listing Expiration 2026-12-31
Marketing Start 2025-07-15

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 62559220
Hyphenated Format 62559-220

Supplemental Identifiers

RxCUI
312136 312137 312138
UPC
0362559221016 0362559222051 0362559222013 0362559220057
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 oxcarbazepine (source: ndc)
Generic Name oxcarbazepine (source: ndc)
Application Number ANDA078005 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (62559-220-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (62559-220-05)
source: ndc

Packages (2)

62559-220-01 100 TABLET, FILM COATED in 1 BOTTLE (62559-220-01) 62559-220-05 500 TABLET, FILM COATED in 1 BOTTLE (62559-220-05)

Ingredients (1)

oxcarbazepine (150 mg/1)

Linked Drug Pages (1)

Oxcarbazepine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00918074-5761-4530-bb20-5cbf3efb84e8", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0362559221016", "0362559222051", "0362559222013", "0362559220057"], "unii": ["VZI5B1W380"], "rxcui": ["312136", "312137", "312138"], "spl_set_id": ["867eaf99-3e31-4f75-bfae-2898804d956d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (62559-220-01)", "package_ndc": "62559-220-01", "marketing_start_date": "20250715"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (62559-220-05)", "package_ndc": "62559-220-05", "marketing_start_date": "20250715"}], "brand_name": "Oxcarbazepine", "product_id": "62559-220_00918074-5761-4530-bb20-5cbf3efb84e8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "62559-220", "generic_name": "Oxcarbazepine", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "150 mg/1"}], "application_number": "ANDA078005", "marketing_category": "ANDA", "marketing_start_date": "20250715", "listing_expiration_date": "20261231"}