oxcarbazepine

Generic: oxcarbazepine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler avpak
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

oxcarbazepine 150 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-679
Product ID 50268-679_2b4c161c-f20b-38d5-e063-6394a90a8a79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215939
Listing Expiration 2026-12-31
Marketing Start 2023-06-07

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 50268679
Hyphenated Format 50268-679

Supplemental Identifiers

RxCUI
312136 312137 312138
UNII
VZI5B1W380
NUI
N0000175753 N0000008486

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 ANDA215939 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-679-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-679-11)
source: ndc

Packages (1)

50268-679-15 50 BLISTER PACK in 1 BOX (50268-679-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-679-11)

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": "2b4c161c-f20b-38d5-e063-6394a90a8a79", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["312136", "312137", "312138"], "spl_set_id": ["fd8da0e9-d69b-7587-e053-6294a90a33c0"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-679-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-679-11)", "package_ndc": "50268-679-15", "marketing_start_date": "20230607"}], "brand_name": "Oxcarbazepine", "product_id": "50268-679_2b4c161c-f20b-38d5-e063-6394a90a8a79", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50268-679", "generic_name": "Oxcarbazepine", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "150 mg/1"}], "application_number": "ANDA215939", "marketing_category": "ANDA", "marketing_start_date": "20230607", "listing_expiration_date": "20261231"}