lamotrigine

Generic: lamotrigine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 250 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-988
Product ID 65162-988_40e5eebb-7577-4c9e-bf1d-f511b8cb4d33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207497
Listing Expiration 2026-12-31
Marketing Start 2018-11-30

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 65162988
Hyphenated Format 65162-988

Supplemental Identifiers

RxCUI
850087 850091 900156 900164 1098608 1146690
UPC
0365162958034 0365162986037 0365162949032 0365162990034 0365162956030
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 (source: ndc)
Generic Name lamotrigine (source: ndc)
Application Number ANDA207497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-988-03)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-988-09)
source: ndc

Packages (2)

65162-988-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-988-03) 65162-988-09 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-988-09)

Ingredients (1)

lamotrigine (250 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": "40e5eebb-7577-4c9e-bf1d-f511b8cb4d33", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0365162958034", "0365162986037", "0365162949032", "0365162990034", "0365162956030"], "unii": ["U3H27498KS"], "rxcui": ["850087", "850091", "900156", "900164", "1098608", "1146690"], "spl_set_id": ["0833d3df-2df1-4abd-abe0-7fb2c0253c80"], "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": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-988-03)", "package_ndc": "65162-988-03", "marketing_start_date": "20181130"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-988-09)", "package_ndc": "65162-988-09", "marketing_start_date": "20181130"}], "brand_name": "Lamotrigine", "product_id": "65162-988_40e5eebb-7577-4c9e-bf1d-f511b8cb4d33", "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": "65162-988", "generic_name": "Lamotrigine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "250 mg/1"}], "application_number": "ANDA207497", "marketing_category": "ANDA", "marketing_start_date": "20181130", "listing_expiration_date": "20261231"}