oxcarbazepine

Generic: oxcarbazepine

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

Drug Facts

Product Profile

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

oxcarbazepine 150 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-183
Product ID 62756-183_56aeed00-02fa-483d-b4be-45362e10f5ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077794
Listing Expiration 2026-12-31
Marketing Start 2007-10-09

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 62756183
Hyphenated Format 62756-183

Supplemental Identifiers

RxCUI
312136 312137 312138
UPC
0362756183834 0362756185838 0362756184831
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 ANDA077794 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (62756-183-08)
  • 500 TABLET, FILM COATED in 1 BOTTLE (62756-183-13)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62756-183-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (62756-183-83)
  • 100 TABLET, FILM COATED in 1 BOTTLE (62756-183-88)
source: ndc

Packages (5)

62756-183-08 100 TABLET, FILM COATED in 1 BOTTLE (62756-183-08) 62756-183-13 500 TABLET, FILM COATED in 1 BOTTLE (62756-183-13) 62756-183-18 1000 TABLET, FILM COATED in 1 BOTTLE (62756-183-18) 62756-183-83 30 TABLET, FILM COATED in 1 BOTTLE (62756-183-83) 62756-183-88 100 TABLET, FILM COATED in 1 BOTTLE (62756-183-88)

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": "56aeed00-02fa-483d-b4be-45362e10f5ff", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0362756183834", "0362756185838", "0362756184831"], "unii": ["VZI5B1W380"], "rxcui": ["312136", "312137", "312138"], "spl_set_id": ["7ecd5eef-46f4-407f-9b63-ba65adb3eced"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (62756-183-08)", "package_ndc": "62756-183-08", "marketing_start_date": "20071009"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (62756-183-13)", "package_ndc": "62756-183-13", "marketing_start_date": "20071009"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62756-183-18)", "package_ndc": "62756-183-18", "marketing_start_date": "20071009"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62756-183-83)", "package_ndc": "62756-183-83", "marketing_start_date": "20071009"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (62756-183-88)", "package_ndc": "62756-183-88", "marketing_start_date": "20071009"}], "brand_name": "Oxcarbazepine", "product_id": "62756-183_56aeed00-02fa-483d-b4be-45362e10f5ff", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "62756-183", "generic_name": "Oxcarbazepine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "150 mg/1"}], "application_number": "ANDA077794", "marketing_category": "ANDA", "marketing_start_date": "20071009", "listing_expiration_date": "20261231"}