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
Routes
ORAL
Active Ingredients

lamotrigine 150 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-229
Product ID 65862-229_fa1b319e-3ee3-41e0-8986-7b42885935f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078956
Listing Expiration 2026-12-31
Marketing Start 2009-01-27

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 65862229
Hyphenated Format 65862-229

Supplemental Identifiers

RxCUI
198427 198428 198429 282401
UPC
0365862228017 0365862229014 0365862230010 0365862230782 0365862227782 0365862229786 0365862227010 0365862228789
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 ANDA078956 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-229-01)
  • 60 TABLET in 1 BOTTLE (65862-229-60)
  • 10 BLISTER PACK in 1 CARTON (65862-229-78) / 10 TABLET in 1 BLISTER PACK (65862-229-10)
  • 1000 TABLET in 1 BOTTLE (65862-229-99)
source: ndc

Packages (4)

65862-229-01 100 TABLET in 1 BOTTLE (65862-229-01) 65862-229-60 60 TABLET in 1 BOTTLE (65862-229-60) 65862-229-78 10 BLISTER PACK in 1 CARTON (65862-229-78) / 10 TABLET in 1 BLISTER PACK (65862-229-10) 65862-229-99 1000 TABLET in 1 BOTTLE (65862-229-99)

Ingredients (1)

lamotrigine (150 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": "fa1b319e-3ee3-41e0-8986-7b42885935f9", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0365862228017", "0365862229014", "0365862230010", "0365862230782", "0365862227782", "0365862229786", "0365862227010", "0365862228789"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "282401"], "spl_set_id": ["a9a4309e-fe43-4a26-a30f-c6577d650336"], "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 in 1 BOTTLE (65862-229-01)", "package_ndc": "65862-229-01", "marketing_start_date": "20090127"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (65862-229-60)", "package_ndc": "65862-229-60", "marketing_start_date": "20090127"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-229-78)  / 10 TABLET in 1 BLISTER PACK (65862-229-10)", "package_ndc": "65862-229-78", "marketing_start_date": "20090127"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-229-99)", "package_ndc": "65862-229-99", "marketing_start_date": "20090127"}], "brand_name": "Lamotrigine", "product_id": "65862-229_fa1b319e-3ee3-41e0-8986-7b42885935f9", "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": "65862-229", "generic_name": "Lamotrigine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "150 mg/1"}], "application_number": "ANDA078956", "marketing_category": "ANDA", "marketing_start_date": "20090127", "listing_expiration_date": "20261231"}