lamotrigine extended-release (10370-256)

Drug Facts

Product Profile

Brand Name lamotrigine extended-release

Generic Name lamotrigine

Labeler par health usa, llc

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

lamotrigine 300 mg/1

Manufacturer

Par Health USA, LLC

Identifiers & Regulatory

Product NDC 10370-256

Product ID 10370-256_1e264688-469f-4a52-9cb7-a46488698a70

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201374

Listing Expiration 2026-12-31

Marketing Start 2026-01-02

Pharmacologic Class

Established (EPC)

anti-epileptic agent [epc] mood stabilizer [epc]

Mechanism of Action

organic cation transporter 2 inhibitors [moa] dihydrofolate reductase inhibitors [moa]

Physiologic Effect

decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10370256

Hyphenated Format 10370-256

Supplemental Identifiers

RxCUI

850087 900156 1098608 1146690

UPC

0310370334118 0310370208112 0310370256113 0310370207115

UNII

U3H27498KS

NUI

N0000175753 N0000008486 N0000175751 N0000187061 N0000000191

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 lamotrigine extended-release (source: ndc)

Generic Name lamotrigine (source: ndc)

Application Number ANDA201374 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-256-11)

source: ndc

Packages (1)

10370-256-11 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-256-11)

Ingredients (1)

lamotrigine (300 mg/1)

Linked Drug Pages (1)

Lamotrigine Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1e264688-469f-4a52-9cb7-a46488698a70", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0310370334118", "0310370208112", "0310370256113", "0310370207115"], "unii": ["U3H27498KS"], "rxcui": ["850087", "900156", "1098608", "1146690"], "spl_set_id": ["d5ec4d58-c669-4ab4-ba62-b71007536854"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]"], "pharm_class_moa": ["Organic Cation Transporter 2 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitors [MoA]"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-256-11)", "package_ndc": "10370-256-11", "marketing_start_date": "20260102"}], "brand_name": "Lamotrigine Extended-Release", "product_id": "10370-256_1e264688-469f-4a52-9cb7-a46488698a70", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Dihydrofolate Reductase Inhibitors [MoA]", "Mood Stabilizer [EPC]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "product_ndc": "10370-256", "generic_name": "lamotrigine", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "300 mg/1"}], "application_number": "ANDA201374", "marketing_category": "ANDA", "marketing_start_date": "20260102", "listing_expiration_date": "20261231"}