oxcarbazepine

Generic: oxcarbazepine

Labeler: advagen pharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler advagen pharma ltd
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/5mL

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-074
Product ID 72888-074_4844e056-6c56-1482-e063-6394a90a018e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215726
Listing Expiration 2027-12-31
Marketing Start 2022-08-31

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 72888074
Hyphenated Format 72888-074

Supplemental Identifiers

RxCUI
283536
UPC
0372888074146
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 ANDA215726 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72888-074-14) / 250 mL in 1 BOTTLE
source: ndc

Packages (1)

72888-074-14 1 BOTTLE in 1 CARTON (72888-074-14) / 250 mL in 1 BOTTLE

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": "4844e056-6c56-1482-e063-6394a90a018e", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0372888074146"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["4ef6a941-a017-40f2-a50a-ab66c43b3347"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72888-074-14)  / 250 mL in 1 BOTTLE", "package_ndc": "72888-074-14", "marketing_start_date": "20240214"}], "brand_name": "OXCARBAZEPINE", "product_id": "72888-074_4844e056-6c56-1482-e063-6394a90a018e", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72888-074", "generic_name": "OXCARBAZEPINE", "labeler_name": "Advagen Pharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXCARBAZEPINE", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/5mL"}], "application_number": "ANDA215726", "marketing_category": "ANDA", "marketing_start_date": "20220831", "listing_expiration_date": "20271231"}