lamotrigine

Generic: lamotrigine

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler avkare
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 200 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-446
Product ID 42291-446_485d3fe4-eadb-a4dc-e063-6294a90ab9f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207497
Listing Expiration 2027-12-31
Marketing Start 2020-05-22

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 42291446
Hyphenated Format 42291-446

Supplemental Identifiers

RxCUI
850087 850091 900156 900164 1098608 1146690
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 ANDA207497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-446-30)
source: ndc

Packages (1)

42291-446-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-446-30)

Ingredients (1)

lamotrigine (200 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": "485d3fe4-eadb-a4dc-e063-6294a90ab9f0", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["850087", "850091", "900156", "900164", "1098608", "1146690"], "spl_set_id": ["a63e19c0-a093-e896-e053-2a95a90a7ccd"], "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": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-446-30)", "package_ndc": "42291-446-30", "marketing_start_date": "20200522"}], "brand_name": "Lamotrigine", "product_id": "42291-446_485d3fe4-eadb-a4dc-e063-6294a90ab9f0", "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": "42291-446", "generic_name": "Lamotrigine", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "200 mg/1"}], "application_number": "ANDA207497", "marketing_category": "ANDA", "marketing_start_date": "20200522", "listing_expiration_date": "20271231"}