lamotrigine

Generic: lamotrigine chewable dispersible

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

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine chewable dispersible
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

lamotrigine 5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-095
Product ID 46708-095_4ea08829-6e98-4a5f-97d0-da2d1ac96dc1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201168
Listing Expiration 2026-12-31
Marketing Start 2016-01-29

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 46708095
Hyphenated Format 46708-095

Supplemental Identifiers

RxCUI
311264 311265
UPC
0346708096304 0346708095307
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 chewable dispersible (source: ndc)
Application Number ANDA201168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-30)
  • 100 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-31)
  • 1000 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-91)
source: ndc

Packages (3)

46708-095-30 30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-30) 46708-095-31 100 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-31) 46708-095-91 1000 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-91)

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": "4ea08829-6e98-4a5f-97d0-da2d1ac96dc1", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0346708096304", "0346708095307"], "unii": ["U3H27498KS"], "rxcui": ["311264", "311265"], "spl_set_id": ["ae6522d4-d824-44aa-afe0-70cdcbd845af"], "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, FOR SUSPENSION in 1 BOTTLE (46708-095-30)", "package_ndc": "46708-095-30", "marketing_start_date": "20160129"}, {"sample": false, "description": "100 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-31)", "package_ndc": "46708-095-31", "marketing_start_date": "20160129"}, {"sample": false, "description": "1000 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-095-91)", "package_ndc": "46708-095-91", "marketing_start_date": "20160129"}], "brand_name": "lamotrigine", "product_id": "46708-095_4ea08829-6e98-4a5f-97d0-da2d1ac96dc1", "dosage_form": "TABLET, FOR SUSPENSION", "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": "46708-095", "generic_name": "lamotrigine chewable dispersible", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "5 mg/1"}], "application_number": "ANDA201168", "marketing_category": "ANDA", "marketing_start_date": "20160129", "listing_expiration_date": "20261231"}