oxcarbazepine

Generic: oxcarbazepine

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler apotex corp.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4129
Product ID 60505-4129_f106ef3d-7def-b2e5-2428-60ecd16326f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213369
Listing Expiration 2026-12-31
Marketing Start 2024-09-03

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 605054129
Hyphenated Format 60505-4129

Supplemental Identifiers

RxCUI
1365653 1365842 1365844
UPC
0360505412976 0360505413072 0360505412877
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 ANDA213369 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4129-5)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4129-7)
source: ndc

Packages (2)

60505-4129-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4129-5) 60505-4129-7 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4129-7)

Ingredients (1)

oxcarbazepine (300 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": "f106ef3d-7def-b2e5-2428-60ecd16326f0", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0360505412976", "0360505413072", "0360505412877"], "unii": ["VZI5B1W380"], "rxcui": ["1365653", "1365842", "1365844"], "spl_set_id": ["a20e4a95-8ee1-e702-003e-e353ec1ee133"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4129-5)", "package_ndc": "60505-4129-5", "marketing_start_date": "20240903"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4129-7)", "package_ndc": "60505-4129-7", "marketing_start_date": "20240903"}], "brand_name": "OXCARBAZEPINE", "product_id": "60505-4129_f106ef3d-7def-b2e5-2428-60ecd16326f0", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "60505-4129", "generic_name": "OXCARBAZEPINE", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXCARBAZEPINE", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/1"}], "application_number": "ANDA213369", "marketing_category": "ANDA", "marketing_start_date": "20240903", "listing_expiration_date": "20261231"}