lamotrigine

Generic: lamotrigine

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 50 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-1435
Product ID 0228-1435_0a4401c8-cfb3-4c11-b068-5c53cb4f7fbb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200672
Marketing Start 2016-04-01
Marketing End 2026-08-31

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 02281435
Hyphenated Format 0228-1435

Supplemental Identifiers

RxCUI
850087 850091 900156 900164 1098608 1146690
UPC
0302281410036 0302281435039
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 ANDA200672 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1435-03)
source: ndc

Packages (1)

0228-1435-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1435-03)

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": "0a4401c8-cfb3-4c11-b068-5c53cb4f7fbb", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0302281410036", "0302281435039"], "unii": ["U3H27498KS"], "rxcui": ["850087", "850091", "900156", "900164", "1098608", "1146690"], "spl_set_id": ["87beaf22-593d-4170-bb58-332c615ef90d"], "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": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1435-03)", "package_ndc": "0228-1435-03", "marketing_end_date": "20260831", "marketing_start_date": "20160401"}], "brand_name": "Lamotrigine", "product_id": "0228-1435_0a4401c8-cfb3-4c11-b068-5c53cb4f7fbb", "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": "0228-1435", "generic_name": "Lamotrigine", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "50 mg/1"}], "application_number": "ANDA200672", "marketing_category": "ANDA", "marketing_end_date": "20260831", "marketing_start_date": "20160401"}