lamotrigine

Generic: lamotrigine

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 250 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-418
Product ID 46708-418_faee013c-cad2-4abb-904c-e6ff79ba778c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211821
Listing Expiration 2026-12-31
Marketing Start 2024-10-07

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 46708418
Hyphenated Format 46708-418

Supplemental Identifiers

RxCUI
900156 1098608 1146690
UPC
0346708417307 0346708419301 0346708418304
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 ANDA211821 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-418-30)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-418-91)
source: ndc

Packages (2)

46708-418-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-418-30) 46708-418-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-418-91)

Ingredients (1)

lamotrigine (250 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": "faee013c-cad2-4abb-904c-e6ff79ba778c", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0346708417307", "0346708419301", "0346708418304"], "unii": ["U3H27498KS"], "rxcui": ["900156", "1098608", "1146690"], "spl_set_id": ["faee013c-cad2-4abb-904c-e6ff79ba778c"], "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": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-418-30)", "package_ndc": "46708-418-30", "marketing_start_date": "20241007"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-418-91)", "package_ndc": "46708-418-91", "marketing_start_date": "20241007"}], "brand_name": "Lamotrigine", "product_id": "46708-418_faee013c-cad2-4abb-904c-e6ff79ba778c", "dosage_form": "TABLET, 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": "46708-418", "generic_name": "Lamotrigine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "250 mg/1"}], "application_number": "ANDA211821", "marketing_category": "ANDA", "marketing_start_date": "20241007", "listing_expiration_date": "20261231"}