lamotrigine

Generic: lamotrigine extended-release

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

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine extended-release
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-022
Product ID 82804-022_39efe933-bfed-4a6a-b270-0883871c5186
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213949
Listing Expiration 2026-12-31
Marketing Start 2021-12-09

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 82804022
Hyphenated Format 82804-022

Supplemental Identifiers

RxCUI
850091
UPC
0382804022304
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 extended-release (source: ndc)
Application Number ANDA213949 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-30)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-60)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-90)
source: ndc

Packages (3)

82804-022-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-30) 82804-022-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-60) 82804-022-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-90)

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": "39efe933-bfed-4a6a-b270-0883871c5186", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0382804022304"], "unii": ["U3H27498KS"], "rxcui": ["850091"], "spl_set_id": ["39efe933-bfed-4a6a-b270-0883871c5186"], "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, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-30)", "package_ndc": "82804-022-30", "marketing_start_date": "20231011"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-60)", "package_ndc": "82804-022-60", "marketing_start_date": "20231011"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-022-90)", "package_ndc": "82804-022-90", "marketing_start_date": "20231011"}], "brand_name": "lamotrigine", "product_id": "82804-022_39efe933-bfed-4a6a-b270-0883871c5186", "dosage_form": "TABLET, FILM COATED, 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": "82804-022", "generic_name": "lamotrigine extended-release", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "50 mg/1"}], "application_number": "ANDA213949", "marketing_category": "ANDA", "marketing_start_date": "20211209", "listing_expiration_date": "20261231"}