lamotrigine

Generic: lamotrigine

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 25 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0289
Product ID 80425-0289_2a9b9724-0258-e829-e063-6394a90a1c07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090170
Listing Expiration 2026-12-31
Marketing Start 2023-03-24

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 804250289
Hyphenated Format 80425-0289

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 ANDA090170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (80425-0289-1)
  • 60 TABLET in 1 BOTTLE (80425-0289-2)
  • 90 TABLET in 1 BOTTLE (80425-0289-3)
source: ndc

Packages (3)

80425-0289-1 30 TABLET in 1 BOTTLE (80425-0289-1) 80425-0289-2 60 TABLET in 1 BOTTLE (80425-0289-2) 80425-0289-3 90 TABLET in 1 BOTTLE (80425-0289-3)

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": "2a9b9724-0258-e829-e063-6394a90a1c07", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["282401"], "spl_set_id": ["f7a86237-ece4-7cc4-e053-6294a90a1308"], "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": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0289-1)", "package_ndc": "80425-0289-1", "marketing_start_date": "20230324"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0289-2)", "package_ndc": "80425-0289-2", "marketing_start_date": "20230324"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0289-3)", "package_ndc": "80425-0289-3", "marketing_start_date": "20230324"}], "brand_name": "Lamotrigine", "product_id": "80425-0289_2a9b9724-0258-e829-e063-6394a90a1c07", "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": "80425-0289", "generic_name": "Lamotrigine", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "25 mg/1"}], "application_number": "ANDA090170", "marketing_category": "ANDA", "marketing_start_date": "20230324", "listing_expiration_date": "20261231"}