lamotrigine

Generic: lamotrigine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 100 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-203
Product ID 43063-203_3edcc3b8-cb38-9986-e063-6294a90ad051
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078947
Listing Expiration 2026-12-31
Marketing Start 2009-01-27

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 43063203
Hyphenated Format 43063-203

Supplemental Identifiers

RxCUI
198427
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 (source: ndc)
Application Number ANDA078947 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-203-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-203-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-203-90)
source: ndc

Packages (3)

43063-203-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-203-30) 43063-203-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-203-60) 43063-203-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-203-90)

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": "3edcc3b8-cb38-9986-e063-6294a90ad051", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["198427"], "spl_set_id": ["f31e1854-6068-4e45-b1e5-6def862fc466"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-203-30)", "package_ndc": "43063-203-30", "marketing_start_date": "20100813"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-203-60)", "package_ndc": "43063-203-60", "marketing_start_date": "20100813"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-203-90)", "package_ndc": "43063-203-90", "marketing_start_date": "20100813"}], "brand_name": "LAMOTRIGINE", "product_id": "43063-203_3edcc3b8-cb38-9986-e063-6294a90ad051", "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": "43063-203", "generic_name": "LAMOTRIGINE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LAMOTRIGINE", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "100 mg/1"}], "application_number": "ANDA078947", "marketing_category": "ANDA", "marketing_start_date": "20090127", "listing_expiration_date": "20261231"}