lamotrigine

Generic: lamotrigine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 150 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-4697
Product ID 63629-4697_e4c53c49-1846-4473-a793-6c9d23b70260
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079132
Listing Expiration 2026-12-31
Marketing Start 2009-01-27

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 636294697
Hyphenated Format 63629-4697

Supplemental Identifiers

RxCUI
198428
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 ANDA079132 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (63629-4697-1)
  • 30 TABLET in 1 BOTTLE (63629-4697-2)
  • 90 TABLET in 1 BOTTLE (63629-4697-3)
  • 120 TABLET in 1 BOTTLE (63629-4697-4)
  • 180 TABLET in 1 BOTTLE (63629-4697-5)
source: ndc

Packages (5)

63629-4697-1 60 TABLET in 1 BOTTLE (63629-4697-1) 63629-4697-2 30 TABLET in 1 BOTTLE (63629-4697-2) 63629-4697-3 90 TABLET in 1 BOTTLE (63629-4697-3) 63629-4697-4 120 TABLET in 1 BOTTLE (63629-4697-4) 63629-4697-5 180 TABLET in 1 BOTTLE (63629-4697-5)

Ingredients (1)

lamotrigine (150 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": "e4c53c49-1846-4473-a793-6c9d23b70260", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["198428"], "spl_set_id": ["d33c4293-347c-49a1-9d98-f291c3dab6da"], "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": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (63629-4697-1)", "package_ndc": "63629-4697-1", "marketing_start_date": "20120405"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (63629-4697-2)", "package_ndc": "63629-4697-2", "marketing_start_date": "20161102"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63629-4697-3)", "package_ndc": "63629-4697-3", "marketing_start_date": "20170921"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (63629-4697-4)", "package_ndc": "63629-4697-4", "marketing_start_date": "20220215"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (63629-4697-5)", "package_ndc": "63629-4697-5", "marketing_start_date": "20220215"}], "brand_name": "Lamotrigine", "product_id": "63629-4697_e4c53c49-1846-4473-a793-6c9d23b70260", "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": "63629-4697", "generic_name": "Lamotrigine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "150 mg/1"}], "application_number": "ANDA079132", "marketing_category": "ANDA", "marketing_start_date": "20090127", "listing_expiration_date": "20261231"}