lamotrigine

Generic: lamotrigine

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

lamotrigine 200 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-322
Product ID 50228-322_ec9440ec-0301-59bb-e053-2a95a90afe94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206382
Listing Expiration 2026-12-31
Marketing Start 2015-11-30

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 50228322
Hyphenated Format 50228-322

Supplemental Identifiers

RxCUI
103968 198430 252478 252479
UPC
0350228319300 0350228320306 0350228321303 0350228322300
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 ANDA206382 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50228-322-01)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50228-322-30)
source: ndc

Packages (2)

50228-322-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50228-322-01) 50228-322-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50228-322-30)

Ingredients (1)

lamotrigine (200 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": "ec9440ec-0301-59bb-e053-2a95a90afe94", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0350228319300", "0350228320306", "0350228321303", "0350228322300"], "unii": ["U3H27498KS"], "rxcui": ["103968", "198430", "252478", "252479"], "spl_set_id": ["de700ac1-4048-467e-abb1-238953261a97"], "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": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50228-322-01)", "package_ndc": "50228-322-01", "marketing_start_date": "20151130"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (50228-322-30)", "package_ndc": "50228-322-30", "marketing_start_date": "20151130"}], "brand_name": "Lamotrigine", "product_id": "50228-322_ec9440ec-0301-59bb-e053-2a95a90afe94", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "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": "50228-322", "generic_name": "Lamotrigine", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "200 mg/1"}], "application_number": "ANDA206382", "marketing_category": "ANDA", "marketing_start_date": "20151130", "listing_expiration_date": "20261231"}