lamotrigine

Generic: lamotrigine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler aurobindo pharma limited
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

lamotrigine 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-361
Product ID 65862-361_a1ae3fa7-d80d-42c3-bac5-5cccaee49ad7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090401
Listing Expiration 2026-12-31
Marketing Start 2009-11-04

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 65862361
Hyphenated Format 65862-361

Supplemental Identifiers

RxCUI
311264 311265
UPC
0365862361011
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 ANDA090401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (65862-361-01)
  • 500 TABLET, CHEWABLE in 1 BOTTLE (65862-361-05)
  • 10 BLISTER PACK in 1 CARTON (65862-361-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
  • 12000 TABLET, CHEWABLE in 1 BOTTLE (65862-361-53)
  • 1000 TABLET, CHEWABLE in 1 BOTTLE (65862-361-99)
source: ndc

Packages (5)

65862-361-01 100 TABLET, CHEWABLE in 1 BOTTLE (65862-361-01) 65862-361-05 500 TABLET, CHEWABLE in 1 BOTTLE (65862-361-05) 65862-361-10 10 BLISTER PACK in 1 CARTON (65862-361-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 65862-361-53 12000 TABLET, CHEWABLE in 1 BOTTLE (65862-361-53) 65862-361-99 1000 TABLET, CHEWABLE in 1 BOTTLE (65862-361-99)

Ingredients (1)

lamotrigine (5 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": "a1ae3fa7-d80d-42c3-bac5-5cccaee49ad7", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0365862361011"], "unii": ["U3H27498KS"], "rxcui": ["311264", "311265"], "spl_set_id": ["e08920c2-04a3-4fb5-acc5-0af3140f82e9"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (65862-361-01)", "package_ndc": "65862-361-01", "marketing_start_date": "20091104"}, {"sample": false, "description": "500 TABLET, CHEWABLE in 1 BOTTLE (65862-361-05)", "package_ndc": "65862-361-05", "marketing_start_date": "20091104"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-361-10)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "65862-361-10", "marketing_start_date": "20091104"}, {"sample": false, "description": "12000 TABLET, CHEWABLE in 1 BOTTLE (65862-361-53)", "package_ndc": "65862-361-53", "marketing_start_date": "20091104"}, {"sample": false, "description": "1000 TABLET, CHEWABLE in 1 BOTTLE (65862-361-99)", "package_ndc": "65862-361-99", "marketing_start_date": "20091104"}], "brand_name": "Lamotrigine", "product_id": "65862-361_a1ae3fa7-d80d-42c3-bac5-5cccaee49ad7", "dosage_form": "TABLET, CHEWABLE", "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": "65862-361", "generic_name": "Lamotrigine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "5 mg/1"}], "application_number": "ANDA090401", "marketing_category": "ANDA", "marketing_start_date": "20091104", "listing_expiration_date": "20261231"}