lamotrigine

Generic: lamotrigine

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler zydus lifesciences limited
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

lamotrigine 5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-689
Product ID 65841-689_c4eb074b-9cd4-4bcd-868c-473d9364061c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078009
Listing Expiration 2026-12-31
Marketing Start 2009-01-23

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 65841689
Hyphenated Format 65841-689

Supplemental Identifiers

RxCUI
198427 198428 198429 199322 249329 282401 311264 311265
UPC
0365841687057
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 ANDA078009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (65841-689-01)
  • 500 TABLET, CHEWABLE in 1 BOTTLE (65841-689-05)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (65841-689-16)
source: ndc

Packages (3)

65841-689-01 100 TABLET, CHEWABLE in 1 BOTTLE (65841-689-01) 65841-689-05 500 TABLET, CHEWABLE in 1 BOTTLE (65841-689-05) 65841-689-16 90 TABLET, CHEWABLE in 1 BOTTLE (65841-689-16)

Ingredients (1)

lamotrigine (5 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": "c4eb074b-9cd4-4bcd-868c-473d9364061c", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0365841687057"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "199322", "249329", "282401", "311264", "311265"], "spl_set_id": ["0f2f7421-56d4-45d0-9d2d-dc1edaede039"], "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": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (65841-689-01)", "package_ndc": "65841-689-01", "marketing_start_date": "20090123"}, {"sample": false, "description": "500 TABLET, CHEWABLE in 1 BOTTLE (65841-689-05)", "package_ndc": "65841-689-05", "marketing_start_date": "20090123"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (65841-689-16)", "package_ndc": "65841-689-16", "marketing_start_date": "20090123"}], "brand_name": "Lamotrigine", "product_id": "65841-689_c4eb074b-9cd4-4bcd-868c-473d9364061c", "dosage_form": "TABLET, CHEWABLE", "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": "65841-689", "generic_name": "Lamotrigine", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "5 mg/1"}], "application_number": "ANDA078009", "marketing_category": "ANDA", "marketing_start_date": "20090123", "listing_expiration_date": "20261231"}