eslicarbazepine acetate

Generic: eslicarbazepine acetate

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eslicarbazepine acetate
Generic Name eslicarbazepine acetate
Labeler apotex corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

eslicarbazepine acetate 400 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4659
Product ID 60505-4659_34bede3a-5e85-4291-a95a-3e4d752e89f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211236
Listing Expiration 2026-12-31
Marketing Start 2025-05-06

Pharmacologic Class

Classes
cytochrome p450 2c19 inhibitors [moa] cytochrome p450 3a4 inducers [moa] decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054659
Hyphenated Format 60505-4659

Supplemental Identifiers

RxCUI
1482507 1482515 1482521 1482525
UPC
0360505465835 0360505466139
UNII
BEA68ZVB2K

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 eslicarbazepine acetate (source: ndc)
Generic Name eslicarbazepine acetate (source: ndc)
Application Number ANDA211236 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (60505-4659-3)
  • 90 TABLET in 1 BOTTLE (60505-4659-9)
source: ndc

Packages (2)

60505-4659-3 30 TABLET in 1 BOTTLE (60505-4659-3) 60505-4659-9 90 TABLET in 1 BOTTLE (60505-4659-9)

Ingredients (1)

eslicarbazepine acetate (400 mg/1)

Linked Drug Pages (1)

Eslicarbazepine Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34bede3a-5e85-4291-a95a-3e4d752e89f9", "openfda": {"upc": ["0360505465835", "0360505466139"], "unii": ["BEA68ZVB2K"], "rxcui": ["1482507", "1482515", "1482521", "1482525"], "spl_set_id": ["22f29752-614f-caaf-b595-9deae8a3e3ff"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (60505-4659-3)", "package_ndc": "60505-4659-3", "marketing_start_date": "20250506"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (60505-4659-9)", "package_ndc": "60505-4659-9", "marketing_start_date": "20250506"}], "brand_name": "Eslicarbazepine Acetate", "product_id": "60505-4659_34bede3a-5e85-4291-a95a-3e4d752e89f9", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "60505-4659", "generic_name": "Eslicarbazepine Acetate", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eslicarbazepine Acetate", "active_ingredients": [{"name": "ESLICARBAZEPINE ACETATE", "strength": "400 mg/1"}], "application_number": "ANDA211236", "marketing_category": "ANDA", "marketing_start_date": "20250506", "listing_expiration_date": "20261231"}