eslicarbazepine acetate

Generic: eslicarbazepine acetate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eslicarbazepine acetate
Generic Name eslicarbazepine acetate
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

eslicarbazepine acetate 600 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-587
Product ID 67877-587_ca4bcb9f-157d-4d49-92f5-6b76745aabe1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211199
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 67877587
Hyphenated Format 67877-587

Supplemental Identifiers

RxCUI
1482507 1482515 1482521 1482525
UPC
0367877588308 0367877586304 0367877585307
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 ANDA211199 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (67877-587-60)
source: ndc

Packages (1)

67877-587-60 60 TABLET in 1 BOTTLE (67877-587-60)

Ingredients (1)

eslicarbazepine acetate (600 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": "ca4bcb9f-157d-4d49-92f5-6b76745aabe1", "openfda": {"upc": ["0367877588308", "0367877586304", "0367877585307"], "unii": ["BEA68ZVB2K"], "rxcui": ["1482507", "1482515", "1482521", "1482525"], "spl_set_id": ["28efe9d2-9d7b-4a7c-8458-098456d06604"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (67877-587-60)", "package_ndc": "67877-587-60", "marketing_start_date": "20250506"}], "brand_name": "Eslicarbazepine Acetate", "product_id": "67877-587_ca4bcb9f-157d-4d49-92f5-6b76745aabe1", "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": "67877-587", "generic_name": "Eslicarbazepine Acetate", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eslicarbazepine Acetate", "active_ingredients": [{"name": "ESLICARBAZEPINE ACETATE", "strength": "600 mg/1"}], "application_number": "ANDA211199", "marketing_category": "ANDA", "marketing_start_date": "20250506", "listing_expiration_date": "20261231"}