oxcarbazepine

Generic: oxcarbazepine

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxcarbazepine 300 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-271
Product ID 72603-271_35ccef4e-f4b4-80c6-e063-6394a90ae254
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215939
Listing Expiration 2026-12-31
Marketing Start 2024-09-01

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 72603271
Hyphenated Format 72603-271

Supplemental Identifiers

RxCUI
312137 312138
UPC
0372603272017
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 ANDA215939 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (72603-271-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72603-271-02)
source: ndc

Packages (2)

72603-271-01 100 TABLET, FILM COATED in 1 BOTTLE (72603-271-01) 72603-271-02 500 TABLET, FILM COATED in 1 BOTTLE (72603-271-02)

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": "35ccef4e-f4b4-80c6-e063-6394a90ae254", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0372603272017"], "unii": ["VZI5B1W380"], "rxcui": ["312137", "312138"], "spl_set_id": ["20d826cd-fa4a-4570-9e10-9d7d10fb725b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72603-271-01)", "package_ndc": "72603-271-01", "marketing_start_date": "20240901"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72603-271-02)", "package_ndc": "72603-271-02", "marketing_start_date": "20250428"}], "brand_name": "OXCARBAZEPINE", "product_id": "72603-271_35ccef4e-f4b4-80c6-e063-6394a90ae254", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72603-271", "generic_name": "OXCARBAZEPINE", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXCARBAZEPINE", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/1"}], "application_number": "ANDA215939", "marketing_category": "ANDA", "marketing_start_date": "20240901", "listing_expiration_date": "20261231"}