lamotrigine

Generic: lamotrigine

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 100 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-2065
Product ID 55154-2065_1f211c99-9d3b-4fb7-8e82-a0e968e59fa6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077633
Listing Expiration 2026-12-31
Marketing Start 2009-09-22

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 551542065
Hyphenated Format 55154-2065

Supplemental Identifiers

RxCUI
198427
UPC
0055154206501
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 ANDA077633 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 BAG (55154-2065-0) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

55154-2065-0 1 BLISTER PACK in 1 BAG (55154-2065-0) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

lamotrigine (100 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": "1f211c99-9d3b-4fb7-8e82-a0e968e59fa6", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0055154206501"], "unii": ["U3H27498KS"], "rxcui": ["198427"], "spl_set_id": ["20e156df-a2b6-4710-b526-0419cd17dd33"], "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": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BAG (55154-2065-0)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "55154-2065-0", "marketing_start_date": "20090922"}], "brand_name": "Lamotrigine", "product_id": "55154-2065_1f211c99-9d3b-4fb7-8e82-a0e968e59fa6", "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": "55154-2065", "generic_name": "Lamotrigine", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "100 mg/1"}], "application_number": "ANDA077633", "marketing_category": "ANDA", "marketing_start_date": "20090922", "listing_expiration_date": "20261231"}