oxcarbazepine

Generic: oxcarbazepine

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxcarbazepine 150 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-691
Product ID 68382-691_f743cc83-a47d-4a48-8be5-516be5c7d7e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211747
Listing Expiration 2026-12-31
Marketing Start 2025-07-10

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 68382691
Hyphenated Format 68382-691

Supplemental Identifiers

RxCUI
312136 312137 312138
UPC
0368382692306 0368382691309 0368382693013 0368382693303 0368382692016 0368382691019
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 ANDA211747 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-691-01)
  • 500 TABLET in 1 BOTTLE (68382-691-05)
  • 10 BLISTER PACK in 1 CARTON (68382-691-30) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

68382-691-01 100 TABLET in 1 BOTTLE (68382-691-01) 68382-691-05 500 TABLET in 1 BOTTLE (68382-691-05) 68382-691-30 10 BLISTER PACK in 1 CARTON (68382-691-30) / 10 TABLET in 1 BLISTER PACK

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": "f743cc83-a47d-4a48-8be5-516be5c7d7e8", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0368382692306", "0368382691309", "0368382693013", "0368382693303", "0368382692016", "0368382691019"], "unii": ["VZI5B1W380"], "rxcui": ["312136", "312137", "312138"], "spl_set_id": ["5048dc87-2d89-434d-be51-4a97b0ce0601"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-691-01)", "package_ndc": "68382-691-01", "marketing_start_date": "20250710"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-691-05)", "package_ndc": "68382-691-05", "marketing_start_date": "20250710"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-691-30)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68382-691-30", "marketing_start_date": "20250710"}], "brand_name": "oxcarbazepine", "product_id": "68382-691_f743cc83-a47d-4a48-8be5-516be5c7d7e8", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68382-691", "generic_name": "oxcarbazepine", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "150 mg/1"}], "application_number": "ANDA211747", "marketing_category": "ANDA", "marketing_start_date": "20250710", "listing_expiration_date": "20261231"}