oxcarbazepine

Generic: oxcarbazepine

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxcarbazepine 300 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-293
Product ID 51991-293_7b71db65-df59-4739-9e8f-77aea32f80b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078069
Listing Expiration 2026-12-31
Marketing Start 2008-01-11

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 51991293
Hyphenated Format 51991-293

Supplemental Identifiers

RxCUI
312136 312137 312138
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 ANDA078069 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (51991-293-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (51991-293-05)
source: ndc

Packages (2)

51991-293-01 100 TABLET, FILM COATED in 1 BOTTLE (51991-293-01) 51991-293-05 500 TABLET, FILM COATED in 1 BOTTLE (51991-293-05)

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": "7b71db65-df59-4739-9e8f-77aea32f80b3", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["312136", "312137", "312138"], "spl_set_id": ["682a1210-b26e-426e-8ffe-d25d91bdd608"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (51991-293-01)", "package_ndc": "51991-293-01", "marketing_start_date": "20080111"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (51991-293-05)", "package_ndc": "51991-293-05", "marketing_start_date": "20080111"}], "brand_name": "OXCARBAZEPINE", "product_id": "51991-293_7b71db65-df59-4739-9e8f-77aea32f80b3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "51991-293", "generic_name": "OXCARBAZEPINE", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXCARBAZEPINE", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/1"}], "application_number": "ANDA078069", "marketing_category": "ANDA", "marketing_start_date": "20080111", "listing_expiration_date": "20261231"}