oxcarbazepine

Generic: oxcarbazepine

Labeler: marlex pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler marlex pharmaceuticals, inc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/5mL

Manufacturer
Marlex Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 10135-798
Product ID 10135-798_38688247-8bdb-ee98-e063-6294a90a8ef6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217782
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

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 10135798
Hyphenated Format 10135-798

Supplemental Identifiers

RxCUI
283536
UPC
0310135798414
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 ANDA217782 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 250 mL in 1 BOTTLE, GLASS (10135-798-41)
source: ndc

Packages (1)

10135-798-41 250 mL in 1 BOTTLE, GLASS (10135-798-41)

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": "38688247-8bdb-ee98-e063-6294a90a8ef6", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0310135798414"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["d3684d55-0564-4849-bdf6-b91f22a3e28c"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 mL in 1 BOTTLE, GLASS (10135-798-41)", "package_ndc": "10135-798-41", "marketing_start_date": "20250501"}], "brand_name": "Oxcarbazepine", "product_id": "10135-798_38688247-8bdb-ee98-e063-6294a90a8ef6", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "10135-798", "generic_name": "Oxcarbazepine", "labeler_name": "Marlex Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/5mL"}], "application_number": "ANDA217782", "marketing_category": "ANDA", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}