lamotrigine

Generic: lamotrigine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lamotrigine 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7008
Product ID 0904-7008_587671e1-07fe-4e56-84f4-8a8ef59be0ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077633
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 09047008
Hyphenated Format 0904-7008

Supplemental Identifiers

RxCUI
198427 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 ANDA077633 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7008-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7008-61 100 BLISTER PACK in 1 CARTON (0904-7008-61) / 1 TABLET in 1 BLISTER PACK

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": "587671e1-07fe-4e56-84f4-8a8ef59be0ba", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["198427", "282401"], "spl_set_id": ["12e0be85-0961-4fe0-b973-83251ecf0f65"], "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": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7008-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7008-61", "marketing_start_date": "20090127"}], "brand_name": "Lamotrigine", "product_id": "0904-7008_587671e1-07fe-4e56-84f4-8a8ef59be0ba", "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": "0904-7008", "generic_name": "Lamotrigine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "100 mg/1"}], "application_number": "ANDA077633", "marketing_category": "ANDA", "marketing_start_date": "20090127", "listing_expiration_date": "20261231"}