lamotrigine

Generic: lamotrigine

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 100 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-005
Product ID 82868-005_4833a1e3-3587-9dee-e063-6394a90ad10d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077633
Listing Expiration 2027-12-31
Marketing Start 2023-08-15

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 82868005
Hyphenated Format 82868-005

Supplemental Identifiers

RxCUI
198427
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
  • 30 TABLET in 1 BOTTLE, PLASTIC (82868-005-30)
source: ndc

Packages (1)

82868-005-30 30 TABLET in 1 BOTTLE, PLASTIC (82868-005-30)

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": "4833a1e3-3587-9dee-e063-6394a90ad10d", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["198427"], "spl_set_id": ["03fd8413-df56-50ab-e063-6394a90a6950"], "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": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (82868-005-30)", "package_ndc": "82868-005-30", "marketing_start_date": "20230815"}], "brand_name": "Lamotrigine", "product_id": "82868-005_4833a1e3-3587-9dee-e063-6394a90ad10d", "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": "82868-005", "generic_name": "Lamotrigine", "labeler_name": "Northwind Health Company, LLC", "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": "20230815", "listing_expiration_date": "20271231"}