lamotrigine

Generic: lamotrigine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lamotrigine 100 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-367
Product ID 42291-367_3ab21195-3410-4321-e063-6294a90a2204
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079132
Listing Expiration 2026-12-31
Marketing Start 2013-04-10

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 42291367
Hyphenated Format 42291-367

Supplemental Identifiers

RxCUI
198427 198428 198429 282401
UPC
0342291368606
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 ANDA079132 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42291-367-01)
  • 1000 TABLET in 1 BOTTLE (42291-367-10)
source: ndc

Packages (2)

42291-367-01 100 TABLET in 1 BOTTLE (42291-367-01) 42291-367-10 1000 TABLET in 1 BOTTLE (42291-367-10)

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": "3ab21195-3410-4321-e063-6294a90a2204", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0342291368606"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "282401"], "spl_set_id": ["fcdb94a8-33be-6375-98ef-6933999d157f"], "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": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42291-367-01)", "package_ndc": "42291-367-01", "marketing_start_date": "20130410"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (42291-367-10)", "package_ndc": "42291-367-10", "marketing_start_date": "20150128"}], "brand_name": "Lamotrigine", "product_id": "42291-367_3ab21195-3410-4321-e063-6294a90a2204", "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": "42291-367", "generic_name": "Lamotrigine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "100 mg/1"}], "application_number": "ANDA079132", "marketing_category": "ANDA", "marketing_start_date": "20130410", "listing_expiration_date": "20261231"}