eslicarbazepine acetate

Generic: eslicarbazepine acetate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eslicarbazepine acetate
Generic Name eslicarbazepine acetate
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

eslicarbazepine acetate 400 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-291
Product ID 68180-291_2c3d221b-f0d3-4845-8bbc-9a4df2f0cc33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211246
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 68180291
Hyphenated Format 68180-291

Supplemental Identifiers

RxCUI
1482507 1482515 1482521 1482525
UPC
0368180290063 0368180293064 0368180292074
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 ANDA211246 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68180-291-06)
source: ndc

Packages (1)

68180-291-06 30 TABLET in 1 BOTTLE (68180-291-06)

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": "2c3d221b-f0d3-4845-8bbc-9a4df2f0cc33", "openfda": {"upc": ["0368180290063", "0368180293064", "0368180292074"], "unii": ["BEA68ZVB2K"], "rxcui": ["1482507", "1482515", "1482521", "1482525"], "spl_set_id": ["999b341f-fe13-4dd9-bb95-9b0d6a817c4c"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68180-291-06)", "package_ndc": "68180-291-06", "marketing_start_date": "20250506"}], "brand_name": "Eslicarbazepine Acetate", "product_id": "68180-291_2c3d221b-f0d3-4845-8bbc-9a4df2f0cc33", "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": "68180-291", "generic_name": "Eslicarbazepine Acetate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eslicarbazepine Acetate", "active_ingredients": [{"name": "ESLICARBAZEPINE ACETATE", "strength": "400 mg/1"}], "application_number": "ANDA211246", "marketing_category": "ANDA", "marketing_start_date": "20250506", "listing_expiration_date": "20261231"}