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 TABLET
Routes
ORAL
Active Ingredients

oxcarbazepine 150 mg/1

Manufacturer
Advagen Pharma Ltd.

Identifiers & Regulatory

Product NDC 72888-462
Product ID 72888-462_49fe26b4-1dcb-832f-e063-6294a90a6195
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207717
Listing Expiration 2027-12-31
Marketing Start 2025-05-20

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 72888462
Hyphenated Format 72888-462

Supplemental Identifiers

RxCUI
312136 312137 312138
UPC
0372888461014 0372888460017 0372888462011 0372888460024 0372888462028 0372888461021
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 ANDA207717 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72888-462-01)
  • 500 TABLET in 1 BOTTLE (72888-462-02)
source: ndc

Packages (2)

72888-462-01 100 TABLET in 1 BOTTLE (72888-462-01) 72888-462-02 500 TABLET in 1 BOTTLE (72888-462-02)

Ingredients (1)

oxcarbazepine (150 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": "49fe26b4-1dcb-832f-e063-6294a90a6195", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0372888461014", "0372888460017", "0372888462011", "0372888460024", "0372888462028", "0372888461021"], "unii": ["VZI5B1W380"], "rxcui": ["312136", "312137", "312138"], "spl_set_id": ["ab4c1f36-82fa-40a2-a31a-227875d0f382"], "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": "100 TABLET in 1 BOTTLE (72888-462-01)", "package_ndc": "72888-462-01", "marketing_start_date": "20250520"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72888-462-02)", "package_ndc": "72888-462-02", "marketing_start_date": "20250520"}], "brand_name": "Oxcarbazepine", "product_id": "72888-462_49fe26b4-1dcb-832f-e063-6294a90a6195", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72888-462", "generic_name": "Oxcarbazepine", "labeler_name": "Advagen Pharma Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "150 mg/1"}], "application_number": "ANDA207717", "marketing_category": "ANDA", "marketing_start_date": "20250520", "listing_expiration_date": "20271231"}