oxcarbazepine

Generic: oxcarbazepine

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

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler advagen pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/1

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-088
Product ID 72888-088_4b920b8e-b260-b6a0-e063-6294a90a3490
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077747
Listing Expiration 2027-12-31
Marketing Start 2021-03-19

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 72888088
Hyphenated Format 72888-088

Supplemental Identifiers

RxCUI
312136 312137 312138
UPC
0372888088303 0372888088013 0372888089058 0372888089300 0372888087016 0372888087054 0372888088051 0372888087306 0372888089010
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 ANDA077747 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (72888-088-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72888-088-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72888-088-30)
source: ndc

Packages (3)

72888-088-01 100 TABLET, FILM COATED in 1 BOTTLE (72888-088-01) 72888-088-05 500 TABLET, FILM COATED in 1 BOTTLE (72888-088-05) 72888-088-30 30 TABLET, FILM COATED in 1 BOTTLE (72888-088-30)

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": "4b920b8e-b260-b6a0-e063-6294a90a3490", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0372888088303", "0372888088013", "0372888089058", "0372888089300", "0372888087016", "0372888087054", "0372888088051", "0372888087306", "0372888089010"], "unii": ["VZI5B1W380"], "rxcui": ["312136", "312137", "312138"], "spl_set_id": ["b0bc10f0-7d1b-4adc-bc59-c48dab58ee5a"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72888-088-01)", "package_ndc": "72888-088-01", "marketing_start_date": "20210319"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72888-088-05)", "package_ndc": "72888-088-05", "marketing_start_date": "20210319"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72888-088-30)", "package_ndc": "72888-088-30", "marketing_start_date": "20210319"}], "brand_name": "Oxcarbazepine", "product_id": "72888-088_4b920b8e-b260-b6a0-e063-6294a90a3490", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72888-088", "generic_name": "oxcarbazepine", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/1"}], "application_number": "ANDA077747", "marketing_category": "ANDA", "marketing_start_date": "20210319", "listing_expiration_date": "20271231"}