eslicarbazepine acetate

Generic: eslicarbazepine acetate

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

Drug Facts

Product Profile

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

eslicarbazepine acetate 200 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-428
Product ID 31722-428_35c91221-dff8-9144-e063-6394a90a57fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211186
Listing Expiration 2026-12-31
Marketing Start 2023-08-03

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 31722428
Hyphenated Format 31722-428

Supplemental Identifiers

RxCUI
1482507 1482515 1482521 1482525
UPC
0331722431309 0331722430906 0331722428309 0331722430609 0331722429306 0331722431903
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 ANDA211186 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (31722-428-30)
  • 10 BLISTER PACK in 1 CARTON (31722-428-32) / 10 TABLET in 1 BLISTER PACK (31722-428-31)
source: ndc

Packages (2)

31722-428-30 30 TABLET in 1 BOTTLE (31722-428-30) 31722-428-32 10 BLISTER PACK in 1 CARTON (31722-428-32) / 10 TABLET in 1 BLISTER PACK (31722-428-31)

Ingredients (1)

eslicarbazepine acetate (200 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": "35c91221-dff8-9144-e063-6394a90a57fb", "openfda": {"upc": ["0331722431309", "0331722430906", "0331722428309", "0331722430609", "0331722429306", "0331722431903"], "unii": ["BEA68ZVB2K"], "rxcui": ["1482507", "1482515", "1482521", "1482525"], "spl_set_id": ["6200ae2e-ac4e-41b6-a1c3-0ea00703d7e3"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (31722-428-30)", "package_ndc": "31722-428-30", "marketing_start_date": "20230803"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (31722-428-32)  / 10 TABLET in 1 BLISTER PACK (31722-428-31)", "package_ndc": "31722-428-32", "marketing_start_date": "20230803"}], "brand_name": "Eslicarbazepine acetate", "product_id": "31722-428_35c91221-dff8-9144-e063-6394a90a57fb", "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": "31722-428", "generic_name": "Eslicarbazepine acetate", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eslicarbazepine acetate", "active_ingredients": [{"name": "ESLICARBAZEPINE ACETATE", "strength": "200 mg/1"}], "application_number": "ANDA211186", "marketing_category": "ANDA", "marketing_start_date": "20230803", "listing_expiration_date": "20261231"}