lamotrigine

Generic: lamotrigine

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

lamotrigine 100 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1528
Product ID 0115-1528_9611e358-6fe1-4f8d-99a2-250a7862a896
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200828
Listing Expiration 2026-12-31
Marketing Start 2015-01-09

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 01151528
Hyphenated Format 0115-1528

Supplemental Identifiers

RxCUI
103968 198430 252478 252479
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 ANDA200828 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0115-1528-08) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1528-15)
source: ndc

Packages (1)

0115-1528-08 3 BLISTER PACK in 1 CARTON (0115-1528-08) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1528-15)

Ingredients (1)

lamotrigine (100 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": "9611e358-6fe1-4f8d-99a2-250a7862a896", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["103968", "198430", "252478", "252479"], "spl_set_id": ["380bddae-5b31-4965-96de-97711d859d11"], "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": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0115-1528-08)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1528-15)", "package_ndc": "0115-1528-08", "marketing_start_date": "20150109"}], "brand_name": "Lamotrigine", "product_id": "0115-1528_9611e358-6fe1-4f8d-99a2-250a7862a896", "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": "0115-1528", "generic_name": "LAMOTRIGINE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "100 mg/1"}], "application_number": "ANDA200828", "marketing_category": "ANDA", "marketing_start_date": "20150109", "listing_expiration_date": "20261231"}