oxcarbazepine

Generic: oxcarbazepine

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler macleods pharmaceuticals limited
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/5mL

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-259
Product ID 33342-259_962098cc-2d84-4723-a296-b110f1fd659e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207300
Listing Expiration 2026-12-31
Marketing Start 2025-07-11

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 33342259
Hyphenated Format 33342-259

Supplemental Identifiers

RxCUI
283536
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 ANDA207300 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (33342-259-67) / 250 mL in 1 BOTTLE
source: ndc

Packages (1)

33342-259-67 1 BOTTLE in 1 CARTON (33342-259-67) / 250 mL in 1 BOTTLE

Ingredients (1)

oxcarbazepine (300 mg/5mL)

Linked Drug Pages (1)

oxcarbazepine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "962098cc-2d84-4723-a296-b110f1fd659e", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["962098cc-2d84-4723-a296-b110f1fd659e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (33342-259-67)  / 250 mL in 1 BOTTLE", "package_ndc": "33342-259-67", "marketing_start_date": "20250711"}], "brand_name": "oxcarbazepine", "product_id": "33342-259_962098cc-2d84-4723-a296-b110f1fd659e", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "33342-259", "generic_name": "oxcarbazepine", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/5mL"}], "application_number": "ANDA207300", "marketing_category": "ANDA", "marketing_start_date": "20250711", "listing_expiration_date": "20261231"}