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 SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 60 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1393
Product ID 51672-1393_440646d8-f538-5968-e063-6394a90ab7cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078734
Listing Expiration 2026-12-31
Marketing Start 2025-08-06

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 516721393
Hyphenated Format 51672-1393

Supplemental Identifiers

RxCUI
283536
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 ANDA078734 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (51672-1393-1) / 250 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

51672-1393-1 1 BOTTLE, GLASS in 1 CARTON (51672-1393-1) / 250 mL in 1 BOTTLE, GLASS

Ingredients (1)

oxcarbazepine (60 mg/mL)

Linked Drug Pages (1)

OXCARBAZEPINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "440646d8-f538-5968-e063-6394a90ab7cd", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["9d5ba8a3-d1ea-4d5b-aafd-3a7ba2d4746c"], "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": "1 BOTTLE, GLASS in 1 CARTON (51672-1393-1)  / 250 mL in 1 BOTTLE, GLASS", "package_ndc": "51672-1393-1", "marketing_start_date": "20250806"}], "brand_name": "OXCARBAZEPINE", "product_id": "51672-1393_440646d8-f538-5968-e063-6394a90ab7cd", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "51672-1393", "generic_name": "OXCARBAZEPINE", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXCARBAZEPINE", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "60 mg/mL"}], "application_number": "ANDA078734", "marketing_category": "ANDA", "marketing_start_date": "20250806", "listing_expiration_date": "20261231"}