oxcarbazepine

Generic: oxcarbazepine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2548
Product ID 71335-2548_99a631d2-4db5-4d59-9d54-a6334d7b9fac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215939
Listing Expiration 2026-12-31
Marketing Start 2022-01-11

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 713352548
Hyphenated Format 71335-2548

Supplemental Identifiers

RxCUI
312137
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 ANDA215939 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-2548-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-2548-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-2548-3)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71335-2548-4)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71335-2548-5)
source: ndc

Packages (5)

71335-2548-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-2548-1) 71335-2548-2 60 TABLET, FILM COATED in 1 BOTTLE (71335-2548-2) 71335-2548-3 90 TABLET, FILM COATED in 1 BOTTLE (71335-2548-3) 71335-2548-4 180 TABLET, FILM COATED in 1 BOTTLE (71335-2548-4) 71335-2548-5 120 TABLET, FILM COATED in 1 BOTTLE (71335-2548-5)

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": "99a631d2-4db5-4d59-9d54-a6334d7b9fac", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["312137"], "spl_set_id": ["23137a89-cbd0-4a5f-8220-f26b7ba54330"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-2548-1)", "package_ndc": "71335-2548-1", "marketing_start_date": "20250121"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-2548-2)", "package_ndc": "71335-2548-2", "marketing_start_date": "20250121"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-2548-3)", "package_ndc": "71335-2548-3", "marketing_start_date": "20250121"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71335-2548-4)", "package_ndc": "71335-2548-4", "marketing_start_date": "20250121"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-2548-5)", "package_ndc": "71335-2548-5", "marketing_start_date": "20250121"}], "brand_name": "Oxcarbazepine", "product_id": "71335-2548_99a631d2-4db5-4d59-9d54-a6334d7b9fac", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "71335-2548", "generic_name": "Oxcarbazepine", "labeler_name": "Bryant Ranch Prepack", "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": "20220111", "listing_expiration_date": "20261231"}