lamotrigine extended release (49884-564)

Drug Facts

Product Profile

Brand Name lamotrigine extended release

Generic Name lamotrigine extended release

Labeler endo usa, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

lamotrigine 200 mg/1

Manufacturer

Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-564

Product ID 49884-564_1b224518-6e15-47d1-b1ee-b1e1d92f70ae

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201791

Listing Expiration 2026-12-31

Marketing Start 2013-01-18

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 49884564

Hyphenated Format 49884-564

Supplemental Identifiers

RxCUI

850087 850091 900156 900164 1098608 1146690

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 extended release (source: ndc)

Generic Name lamotrigine extended release (source: ndc)

Application Number ANDA201791 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (49884-564-01)
500 TABLET in 1 BOTTLE (49884-564-05)
30 TABLET in 1 BOTTLE (49884-564-11)

source: ndc

Packages (3)

49884-564-01 100 TABLET in 1 BOTTLE (49884-564-01) 49884-564-05 500 TABLET in 1 BOTTLE (49884-564-05) 49884-564-11 30 TABLET in 1 BOTTLE (49884-564-11)

Ingredients (1)

lamotrigine (200 mg/1)

Linked Drug Pages (1)

Lamotrigine Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1b224518-6e15-47d1-b1ee-b1e1d92f70ae", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["850087", "850091", "900156", "900164", "1098608", "1146690"], "spl_set_id": ["fb59c76a-9b6f-40ea-ac3a-58c3195c4377"], "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": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (49884-564-01)", "package_ndc": "49884-564-01", "marketing_start_date": "20130118"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (49884-564-05)", "package_ndc": "49884-564-05", "marketing_start_date": "20130118"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (49884-564-11)", "package_ndc": "49884-564-11", "marketing_start_date": "20130118"}], "brand_name": "Lamotrigine Extended Release", "product_id": "49884-564_1b224518-6e15-47d1-b1ee-b1e1d92f70ae", "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": "49884-564", "generic_name": "lamotrigine extended release", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine Extended Release", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "200 mg/1"}], "application_number": "ANDA201791", "marketing_category": "ANDA", "marketing_start_date": "20130118", "listing_expiration_date": "20261231"}