lamictal

Generic: lamotrigine

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamictal
Generic Name lamotrigine
Labeler glaxosmithkline llc
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

lamotrigine 25 mg/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0527
Product ID 0173-0527_4492fd3c-e068-4599-8a10-0b26ea2a4f91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020764
Listing Expiration 2026-12-31
Marketing Start 1998-09-03

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 01730527
Hyphenated Format 0173-0527

Supplemental Identifiers

RxCUI
103968 105018 105019 108782 198427 198428 198429 198430 201239 201240 206201 252478 252479 282401 311264 311265 349010 542426 751139 751563 753451 795772 795774 795778 849049 849050 849051 849052 851748 851749 851750 851751 851752 851753
UPC
0301730526007 0301730644602 0301730699008 0301730642554 0301730643605 0301730527004
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 lamictal (source: ndc)
Generic Name lamotrigine (source: ndc)
Application Number NDA020764 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FOR SUSPENSION in 1 BOTTLE (0173-0527-00)
source: ndc

Packages (1)

0173-0527-00 100 TABLET, FOR SUSPENSION in 1 BOTTLE (0173-0527-00)

Ingredients (1)

lamotrigine (25 mg/1)

Linked Drug Pages (1)

LAMICTAL, LAMICTAL ODT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4492fd3c-e068-4599-8a10-0b26ea2a4f91", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0301730526007", "0301730644602", "0301730699008", "0301730642554", "0301730643605", "0301730527004"], "unii": ["U3H27498KS"], "rxcui": ["103968", "105018", "105019", "108782", "198427", "198428", "198429", "198430", "201239", "201240", "206201", "252478", "252479", "282401", "311264", "311265", "349010", "542426", "751139", "751563", "753451", "795772", "795774", "795778", "849049", "849050", "849051", "849052", "851748", "851749", "851750", "851751", "851752", "851753"], "spl_set_id": ["d7e3572d-56fe-4727-2bb4-013ccca22678"], "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": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FOR SUSPENSION in 1 BOTTLE (0173-0527-00)", "package_ndc": "0173-0527-00", "marketing_start_date": "19980903"}], "brand_name": "LAMICTAL", "product_id": "0173-0527_4492fd3c-e068-4599-8a10-0b26ea2a4f91", "dosage_form": "TABLET, FOR SUSPENSION", "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": "0173-0527", "generic_name": "lamotrigine", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LAMICTAL", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "25 mg/1"}], "application_number": "NDA020764", "marketing_category": "NDA", "marketing_start_date": "19980903", "listing_expiration_date": "20261231"}