oxcarbazepine

Generic: oxcarbazepine

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

oxcarbazepine 600 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7866
Product ID 68788-7866_549f1700-86c6-4e21-9391-08de6ef3cbf2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078069
Listing Expiration 2026-12-31
Marketing Start 2021-02-15

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 687887866
Hyphenated Format 68788-7866

Supplemental Identifiers

RxCUI
312138
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 ANDA078069 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-7866-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-7866-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-7866-9)
source: ndc

Packages (3)

68788-7866-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-7866-3) 68788-7866-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-7866-6) 68788-7866-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-7866-9)

Ingredients (1)

oxcarbazepine (600 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": "549f1700-86c6-4e21-9391-08de6ef3cbf2", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["312138"], "spl_set_id": ["e156339c-f79e-4a20-b9da-f50bea948213"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-7866-3)", "package_ndc": "68788-7866-3", "marketing_start_date": "20210215"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-7866-6)", "package_ndc": "68788-7866-6", "marketing_start_date": "20210215"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-7866-9)", "package_ndc": "68788-7866-9", "marketing_start_date": "20210215"}], "brand_name": "OXCARBAZEPINE", "product_id": "68788-7866_549f1700-86c6-4e21-9391-08de6ef3cbf2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68788-7866", "generic_name": "OXCARBAZEPINE", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXCARBAZEPINE", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "600 mg/1"}], "application_number": "ANDA078069", "marketing_category": "ANDA", "marketing_start_date": "20210215", "listing_expiration_date": "20261231"}