oxcarbazepine

Generic: oxcarbazepine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxcarbazepine 300 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1640
Product ID 67046-1640_47b9209b-398e-1d7a-e063-6394a90a4adc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078005
Listing Expiration 2027-12-31
Marketing Start 2026-01-06

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 670461640
Hyphenated Format 67046-1640

Supplemental Identifiers

RxCUI
312137
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 ANDA078005 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1640-3)
source: ndc

Packages (1)

67046-1640-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1640-3)

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": "47b9209b-398e-1d7a-e063-6394a90a4adc", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["312137"], "spl_set_id": ["47b92168-6832-1e0b-e063-6394a90a079a"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1640-3)", "package_ndc": "67046-1640-3", "marketing_start_date": "20260106"}], "brand_name": "Oxcarbazepine", "product_id": "67046-1640_47b9209b-398e-1d7a-e063-6394a90a4adc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "67046-1640", "generic_name": "Oxcarbazepine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/1"}], "application_number": "ANDA078005", "marketing_category": "ANDA", "marketing_start_date": "20260106", "listing_expiration_date": "20271231"}