oxcarbazepine

Generic: oxcarbazepine

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1843
Product ID 70771-1843_905fd0b0-fd53-48f5-83ff-129a5f5f104c
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 707711843
Hyphenated Format 70771-1843

Supplemental Identifiers

RxCUI
312136 312137 312138
UPC
0370771184415 0370771184217 0370771184316
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
  • 300 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1843-0)
  • 100 TABLET in 1 BOTTLE (70771-1843-1)
  • 10 BLISTER PACK in 1 CARTON (70771-1843-4) / 10 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (70771-1843-5)
source: ndc

Packages (4)

70771-1843-0 1000 TABLET in 1 BOTTLE (70771-1843-0) 70771-1843-1 100 TABLET in 1 BOTTLE (70771-1843-1) 70771-1843-4 10 BLISTER PACK in 1 CARTON (70771-1843-4) / 10 TABLET in 1 BLISTER PACK 70771-1843-5 500 TABLET in 1 BOTTLE (70771-1843-5)

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": "905fd0b0-fd53-48f5-83ff-129a5f5f104c", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0370771184415", "0370771184217", "0370771184316"], "unii": ["VZI5B1W380"], "rxcui": ["312136", "312137", "312138"], "spl_set_id": ["e23d8a74-b47b-462a-b09c-90bdd58a032e"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1843-0)", "package_ndc": "70771-1843-0", "marketing_start_date": "20250710"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1843-1)", "package_ndc": "70771-1843-1", "marketing_start_date": "20250710"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1843-4)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70771-1843-4", "marketing_start_date": "20250710"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70771-1843-5)", "package_ndc": "70771-1843-5", "marketing_start_date": "20250710"}], "brand_name": "oxcarbazepine", "product_id": "70771-1843_905fd0b0-fd53-48f5-83ff-129a5f5f104c", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70771-1843", "generic_name": "oxcarbazepine", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/1"}], "application_number": "ANDA211747", "marketing_category": "ANDA", "marketing_start_date": "20250710", "listing_expiration_date": "20261231"}