lamictal xr

Generic: lamotrigine

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamictal xr
Generic Name lamotrigine
Labeler glaxosmithkline llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 300 mg/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0761
Product ID 0173-0761_0c7b21d8-3c32-4c65-95cd-cada0421d8e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022115
Listing Expiration 2026-12-31
Marketing Start 2011-03-31

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 01730761
Hyphenated Format 0173-0761

Supplemental Identifiers

RxCUI
850087 850091 900145 900156 900157 900164 900165 900169 900865 900866 900890 900891 900983 900984 1098608 1098610 1146690 1146692
UPC
0301730756008 0301730757005 0301730761002 0301730754004 0301730781000
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 lamictal xr (source: ndc)
Generic Name lamotrigine (source: ndc)
Application Number NDA022115 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0761-00)
source: ndc

Packages (1)

0173-0761-00 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0761-00)

Ingredients (1)

lamotrigine (300 mg/1)

Linked Drug Pages (1)

LAMICTAL XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0c7b21d8-3c32-4c65-95cd-cada0421d8e3", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0301730756008", "0301730757005", "0301730761002", "0301730754004", "0301730781000"], "unii": ["U3H27498KS"], "rxcui": ["850087", "850091", "900145", "900156", "900157", "900164", "900165", "900169", "900865", "900866", "900890", "900891", "900983", "900984", "1098608", "1098610", "1146690", "1146692"], "spl_set_id": ["3e2c9a35-6a39-41d7-ad84-3c0bb8894b09"], "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": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0761-00)", "package_ndc": "0173-0761-00", "marketing_start_date": "20110331"}], "brand_name": "LAMICTAL XR", "product_id": "0173-0761_0c7b21d8-3c32-4c65-95cd-cada0421d8e3", "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": "0173-0761", "generic_name": "lamotrigine", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LAMICTAL", "brand_name_suffix": "XR", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "300 mg/1"}], "application_number": "NDA022115", "marketing_category": "NDA", "marketing_start_date": "20110331", "listing_expiration_date": "20261231"}