eslicarbazepine acetate

Generic: eslicarbazepine acetate

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eslicarbazepine acetate
Generic Name eslicarbazepine acetate
Labeler torrent pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

eslicarbazepine acetate 400 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-539
Product ID 13668-539_3b2943e4-21ea-828b-e063-6294a90a275b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211227
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 13668539
Hyphenated Format 13668-539

Supplemental Identifiers

RxCUI
1482507 1482515 1482521 1482525
UPC
0313668540307 0313668539301 0313668538304 0313668541304
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 ANDA211227 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (13668-539-05)
  • 30 TABLET in 1 BOTTLE (13668-539-30)
  • 60 TABLET in 1 BOTTLE (13668-539-60)
source: ndc

Packages (3)

13668-539-05 500 TABLET in 1 BOTTLE (13668-539-05) 13668-539-30 30 TABLET in 1 BOTTLE (13668-539-30) 13668-539-60 60 TABLET in 1 BOTTLE (13668-539-60)

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": "3b2943e4-21ea-828b-e063-6294a90a275b", "openfda": {"upc": ["0313668540307", "0313668539301", "0313668538304", "0313668541304"], "unii": ["BEA68ZVB2K"], "rxcui": ["1482507", "1482515", "1482521", "1482525"], "spl_set_id": ["d279e461-2611-4f5c-938d-5d117612894f"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (13668-539-05)", "package_ndc": "13668-539-05", "marketing_start_date": "20250506"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13668-539-30)", "package_ndc": "13668-539-30", "marketing_start_date": "20250506"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (13668-539-60)", "package_ndc": "13668-539-60", "marketing_start_date": "20250506"}], "brand_name": "Eslicarbazepine acetate", "product_id": "13668-539_3b2943e4-21ea-828b-e063-6294a90a275b", "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": "13668-539", "generic_name": "Eslicarbazepine acetate", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eslicarbazepine acetate", "active_ingredients": [{"name": "ESLICARBAZEPINE ACETATE", "strength": "400 mg/1"}], "application_number": "ANDA211227", "marketing_category": "ANDA", "marketing_start_date": "20250506", "listing_expiration_date": "20261231"}