lamotrigine

Generic: lamotrigine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 100 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-319
Product ID 68084-319_275ca27b-4ae2-edea-e063-6394a90ab0c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077633
Listing Expiration 2026-12-31
Marketing Start 2009-07-07

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 68084319
Hyphenated Format 68084-319

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 BOX, UNIT-DOSE (68084-319-01) / 1 TABLET in 1 BLISTER PACK (68084-319-11)
source: ndc

Packages (1)

68084-319-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-319-01) / 1 TABLET in 1 BLISTER PACK (68084-319-11)

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": "275ca27b-4ae2-edea-e063-6394a90ab0c7", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["198427", "282401"], "spl_set_id": ["35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234"], "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": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-319-01)  / 1 TABLET in 1 BLISTER PACK (68084-319-11)", "package_ndc": "68084-319-01", "marketing_start_date": "20090707"}], "brand_name": "Lamotrigine", "product_id": "68084-319_275ca27b-4ae2-edea-e063-6394a90ab0c7", "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": "68084-319", "generic_name": "Lamotrigine", "labeler_name": "American Health Packaging", "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": "20090707", "listing_expiration_date": "20261231"}