oxcarbazepine

Generic: oxcarbazepine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxcarbazepine 600 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7264
Product ID 0904-7264_55b0fa69-7b11-49df-972a-e1d39b35b322
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078069
Marketing Start 2022-11-07
Marketing End 2027-02-28

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 09047264
Hyphenated Format 0904-7264

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 ANDA078069 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7264-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7264-61 100 BLISTER PACK in 1 CARTON (0904-7264-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

oxcarbazepine (600 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": "55b0fa69-7b11-49df-972a-e1d39b35b322", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["312136", "312137", "312138"], "spl_set_id": ["b1d54def-057d-4608-bc8f-1d967ac3ec91"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7264-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7264-61", "marketing_end_date": "20270228", "marketing_start_date": "20221107"}], "brand_name": "OXCARBAZEPINE", "product_id": "0904-7264_55b0fa69-7b11-49df-972a-e1d39b35b322", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "0904-7264", "generic_name": "OXCARBAZEPINE", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXCARBAZEPINE", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "600 mg/1"}], "application_number": "ANDA078069", "marketing_category": "ANDA", "marketing_end_date": "20270228", "marketing_start_date": "20221107"}