oxcarbazepine

Generic: oxcarbazepine

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler bionpharma inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/5mL

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-125
Product ID 69452-125_44eb29ac-e607-a84a-e063-6394a90a9e72
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209652
Listing Expiration 2026-12-31
Marketing Start 2023-02-14

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 69452125
Hyphenated Format 69452-125

Supplemental Identifiers

RxCUI
283536
UPC
0369452125502
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 ANDA209652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (69452-125-50) / 250 mL in 1 BOTTLE, GLASS
  • 1 BOTTLE, PLASTIC in 1 CARTON (69452-125-51) / 250 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

69452-125-50 1 BOTTLE, GLASS in 1 CARTON (69452-125-50) / 250 mL in 1 BOTTLE, GLASS 69452-125-51 1 BOTTLE, PLASTIC in 1 CARTON (69452-125-51) / 250 mL in 1 BOTTLE, PLASTIC

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": "44eb29ac-e607-a84a-e063-6394a90a9e72", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0369452125502"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["ec033897-21b4-4d08-83de-042783e89251"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (69452-125-50)  / 250 mL in 1 BOTTLE, GLASS", "package_ndc": "69452-125-50", "marketing_start_date": "20230214"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (69452-125-51)  / 250 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69452-125-51", "marketing_start_date": "20251201"}], "brand_name": "Oxcarbazepine", "product_id": "69452-125_44eb29ac-e607-a84a-e063-6394a90a9e72", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69452-125", "generic_name": "Oxcarbazepine", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/5mL"}], "application_number": "ANDA209652", "marketing_category": "ANDA", "marketing_start_date": "20230214", "listing_expiration_date": "20261231"}