oxcarbazepine

Generic: oxcarbazepine

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-612
Product ID 50742-612_69d2a354-3ced-494f-bda2-f3f5c4635eaa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215796
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

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 50742612
Hyphenated Format 50742-612

Supplemental Identifiers

RxCUI
1365653 1365842 1365844
UPC
0350742611010 0350742612017 0350742613014
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 ANDA215796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-612-01)
source: ndc

Packages (1)

50742-612-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-612-01)

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": "69d2a354-3ced-494f-bda2-f3f5c4635eaa", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0350742611010", "0350742612017", "0350742613014"], "unii": ["VZI5B1W380"], "rxcui": ["1365653", "1365842", "1365844"], "spl_set_id": ["70798ca9-0eda-49c0-8a7c-b775b6ae3d69"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-612-01)", "package_ndc": "50742-612-01", "marketing_start_date": "20250601"}], "brand_name": "Oxcarbazepine", "product_id": "50742-612_69d2a354-3ced-494f-bda2-f3f5c4635eaa", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "50742-612", "generic_name": "Oxcarbazepine", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/1"}], "application_number": "ANDA215796", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}