lamotrigine

Generic: lamotrigine

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler proficient rx lp
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-105
Product ID 82804-105_ffa46cb2-16e7-45f3-9940-5cb88d0cda9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203370
Listing Expiration 2026-12-31
Marketing Start 2013-12-23

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 82804105
Hyphenated Format 82804-105

Supplemental Identifiers

RxCUI
850091
UPC
0382804105304
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 ANDA203370 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-90)
source: ndc

Packages (3)

82804-105-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-30) 82804-105-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-60) 82804-105-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-90)

Ingredients (1)

lamotrigine (50 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": "ffa46cb2-16e7-45f3-9940-5cb88d0cda9d", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0382804105304"], "unii": ["U3H27498KS"], "rxcui": ["850091"], "spl_set_id": ["ffa46cb2-16e7-45f3-9940-5cb88d0cda9d"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-30)", "package_ndc": "82804-105-30", "marketing_start_date": "20240513"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-60)", "package_ndc": "82804-105-60", "marketing_start_date": "20240513"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-105-90)", "package_ndc": "82804-105-90", "marketing_start_date": "20240513"}], "brand_name": "Lamotrigine", "product_id": "82804-105_ffa46cb2-16e7-45f3-9940-5cb88d0cda9d", "dosage_form": "TABLET, EXTENDED RELEASE", "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": "82804-105", "generic_name": "Lamotrigine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "50 mg/1"}], "application_number": "ANDA203370", "marketing_category": "ANDA", "marketing_start_date": "20131223", "listing_expiration_date": "20261231"}