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
Routes
ORAL
Active Ingredients

lamotrigine 150 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-276
Product ID 46708-276_1f960fe8-22d3-4836-9d4e-f53d74a6c590
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090607
Listing Expiration 2026-12-31
Marketing Start 2013-01-01

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 46708276
Hyphenated Format 46708-276

Supplemental Identifiers

RxCUI
198427 198428 198429 282401
UPC
0346708275303 0346708277307 0346708274306
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 ANDA090607 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (46708-276-30)
  • 100 TABLET in 1 BOTTLE (46708-276-31)
  • 60 TABLET in 1 BOTTLE (46708-276-60)
  • 500 TABLET in 1 BOTTLE (46708-276-71)
  • 1000 TABLET in 1 BOTTLE (46708-276-91)
source: ndc

Packages (5)

46708-276-30 30 TABLET in 1 BOTTLE (46708-276-30) 46708-276-31 100 TABLET in 1 BOTTLE (46708-276-31) 46708-276-60 60 TABLET in 1 BOTTLE (46708-276-60) 46708-276-71 500 TABLET in 1 BOTTLE (46708-276-71) 46708-276-91 1000 TABLET in 1 BOTTLE (46708-276-91)

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": "1f960fe8-22d3-4836-9d4e-f53d74a6c590", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0346708275303", "0346708277307", "0346708274306"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "282401"], "spl_set_id": ["ccb33cd0-e5f7-4a50-8b55-ad7c432cdb77"], "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 in 1 BOTTLE (46708-276-30)", "package_ndc": "46708-276-30", "marketing_start_date": "20130101"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-276-31)", "package_ndc": "46708-276-31", "marketing_start_date": "20130101"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (46708-276-60)", "package_ndc": "46708-276-60", "marketing_start_date": "20130101"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (46708-276-71)", "package_ndc": "46708-276-71", "marketing_start_date": "20130101"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-276-91)", "package_ndc": "46708-276-91", "marketing_start_date": "20130101"}], "brand_name": "Lamotrigine", "product_id": "46708-276_1f960fe8-22d3-4836-9d4e-f53d74a6c590", "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": "46708-276", "generic_name": "Lamotrigine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "150 mg/1"}], "application_number": "ANDA090607", "marketing_category": "ANDA", "marketing_start_date": "20130101", "listing_expiration_date": "20261231"}