lamotrigine

Generic: lamotrigine

Labeler: advagen pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler advagen pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 25 mg/1

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-025
Product ID 72888-025_43efd790-7e05-d37a-e063-6294a90a4156
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078625
Listing Expiration 2026-12-31
Marketing Start 2021-10-29

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 72888025
Hyphenated Format 72888-025

Supplemental Identifiers

RxCUI
198427 198428 198429 282401
UPC
0372888026008 0372888028606 0372888025056 0372888027050 0372888026053 0372888025018 0372888026015 0372888027609 0372888025001 0372888028057
UNII
U3H27498KS
NUI
N0000175753 N0000008486 N0000175751 N0000187061 N0000000191

Packaging Origin

Original Packager
true

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 ANDA078625 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (72888-025-00)
  • 100 TABLET in 1 BOTTLE (72888-025-01)
  • 500 TABLET in 1 BOTTLE (72888-025-05)
source: ndc

Packages (3)

72888-025-00 1000 TABLET in 1 BOTTLE (72888-025-00) 72888-025-01 100 TABLET in 1 BOTTLE (72888-025-01) 72888-025-05 500 TABLET in 1 BOTTLE (72888-025-05)

Ingredients (1)

lamotrigine (25 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": "43efd790-7e05-d37a-e063-6294a90a4156", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0372888026008", "0372888028606", "0372888025056", "0372888027050", "0372888026053", "0372888025018", "0372888026015", "0372888027609", "0372888025001", "0372888028057"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "282401"], "spl_set_id": ["4ca9d713-ab63-48bf-9386-29301a842e60"], "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": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (72888-025-00)", "package_ndc": "72888-025-00", "marketing_start_date": "20211029"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (72888-025-01)", "package_ndc": "72888-025-01", "marketing_start_date": "20211029"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72888-025-05)", "package_ndc": "72888-025-05", "marketing_start_date": "20211029"}], "brand_name": "Lamotrigine", "product_id": "72888-025_43efd790-7e05-d37a-e063-6294a90a4156", "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": "72888-025", "generic_name": "Lamotrigine", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "25 mg/1"}], "application_number": "ANDA078625", "marketing_category": "ANDA", "marketing_start_date": "20211029", "listing_expiration_date": "20261231"}