lamotrigine

Generic: lamotrigine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 25 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1573
Product ID 67046-1573_3dfdcaf5-56e5-051a-e063-6294a90a61b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078956
Listing Expiration 2026-12-31
Marketing Start 2025-09-04

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 670461573
Hyphenated Format 67046-1573

Supplemental Identifiers

RxCUI
282401
UNII
U3H27498KS
NUI
N0000175753 N0000008486 N0000175751 N0000187061 N0000000191

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 (source: ndc)
Generic Name lamotrigine (source: ndc)
Application Number ANDA078956 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1573-3)
source: ndc

Packages (1)

67046-1573-3 30 TABLET in 1 BLISTER PACK (67046-1573-3)

Ingredients (1)

lamotrigine (25 mg/1)

Linked Drug Pages (1)

Lamotrigine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3dfdcaf5-56e5-051a-e063-6294a90a61b2", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["282401"], "spl_set_id": ["3dfdcc2d-b7c5-7abf-e063-6394a90a24a6"], "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": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1573-3)", "package_ndc": "67046-1573-3", "marketing_start_date": "20250904"}], "brand_name": "Lamotrigine", "product_id": "67046-1573_3dfdcaf5-56e5-051a-e063-6294a90a61b2", "dosage_form": "TABLET", "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": "67046-1573", "generic_name": "Lamotrigine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "25 mg/1"}], "application_number": "ANDA078956", "marketing_category": "ANDA", "marketing_start_date": "20250904", "listing_expiration_date": "20261231"}