aptiom

Generic: eslicarbazepine acetate

Labeler: sumitomo pharma america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aptiom
Generic Name eslicarbazepine acetate
Labeler sumitomo pharma america, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

eslicarbazepine acetate 800 mg/1

Manufacturer
Sumitomo Pharma America, Inc.

Identifiers & Regulatory

Product NDC 63402-208
Product ID 63402-208_3af99c5d-50e2-4336-8a5e-e93b6cf3618a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022416
Listing Expiration 2026-12-31
Marketing Start 2014-04-07

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 63402208
Hyphenated Format 63402-208

Supplemental Identifiers

RxCUI
1482507 1482513 1482515 1482517 1482521 1482523 1482525 1482527 1491642 1491643
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 aptiom (source: ndc)
Generic Name eslicarbazepine acetate (source: ndc)
Application Number NDA022416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (63402-208-28) / 7 TABLET in 1 BLISTER PACK (63402-208-07)
  • 30 TABLET in 1 BOTTLE (63402-208-30)
source: ndc

Packages (2)

63402-208-28 4 BLISTER PACK in 1 CARTON (63402-208-28) / 7 TABLET in 1 BLISTER PACK (63402-208-07) 63402-208-30 30 TABLET in 1 BOTTLE (63402-208-30)

Ingredients (1)

eslicarbazepine acetate (800 mg/1)

Linked Drug Pages (1)

Aptiom ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3af99c5d-50e2-4336-8a5e-e93b6cf3618a", "openfda": {"unii": ["BEA68ZVB2K"], "rxcui": ["1482507", "1482513", "1482515", "1482517", "1482521", "1482523", "1482525", "1482527", "1491642", "1491643"], "spl_set_id": ["3d0c9554-eaeb-4694-8089-00133fcadce3"], "manufacturer_name": ["Sumitomo Pharma America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63402-208-28)  / 7 TABLET in 1 BLISTER PACK (63402-208-07)", "package_ndc": "63402-208-28", "marketing_start_date": "20140407"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (63402-208-30)", "package_ndc": "63402-208-30", "marketing_start_date": "20140407"}], "brand_name": "Aptiom", "product_id": "63402-208_3af99c5d-50e2-4336-8a5e-e93b6cf3618a", "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": "63402-208", "generic_name": "ESLICARBAZEPINE ACETATE", "labeler_name": "Sumitomo Pharma America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aptiom", "active_ingredients": [{"name": "ESLICARBAZEPINE ACETATE", "strength": "800 mg/1"}], "application_number": "NDA022416", "marketing_category": "NDA", "marketing_start_date": "20140407", "listing_expiration_date": "20261231"}