oxcarbazepine

Generic: oxcarbazepine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxcarbazepine 150 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-573
Product ID 72189-573_21b0cc84-b64b-75de-e063-6294a90a9dd0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077802
Listing Expiration 2026-12-31
Marketing Start 2024-09-09

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 72189573
Hyphenated Format 72189-573

Supplemental Identifiers

RxCUI
312136
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 ANDA077802 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (72189-573-60)
source: ndc

Packages (1)

72189-573-60 60 TABLET, FILM COATED in 1 BOTTLE (72189-573-60)

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": "21b0cc84-b64b-75de-e063-6294a90a9dd0", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["312136"], "spl_set_id": ["21b0cc84-b64a-75de-e063-6294a90a9dd0"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72189-573-60)", "package_ndc": "72189-573-60", "marketing_start_date": "20240909"}], "brand_name": "Oxcarbazepine", "product_id": "72189-573_21b0cc84-b64b-75de-e063-6294a90a9dd0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72189-573", "generic_name": "Oxcarbazepine", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "150 mg/1"}], "application_number": "ANDA077802", "marketing_category": "ANDA", "marketing_start_date": "20240909", "listing_expiration_date": "20261231"}