lamotrigine

Generic: lamotrigine

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

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler alembic pharmaceuticals inc.
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

lamotrigine 5 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-095
Product ID 62332-095_8b09deb8-500f-428a-b588-6a238c7c553c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201168
Listing Expiration 2027-12-31
Marketing Start 2014-04-11

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 62332095
Hyphenated Format 62332-095

Supplemental Identifiers

UPC
0362332096305 0362332095308
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 ANDA201168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-30)
  • 100 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-31)
  • 1000 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-91)
source: ndc

Packages (3)

62332-095-30 30 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-30) 62332-095-31 100 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-31) 62332-095-91 1000 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-91)

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": "8b09deb8-500f-428a-b588-6a238c7c553c", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0362332096305", "0362332095308"], "unii": ["U3H27498KS"], "spl_set_id": ["05cba628-b12c-44d8-89a8-3522fe417cc1"], "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 Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-30)", "package_ndc": "62332-095-30", "marketing_start_date": "20140411"}, {"sample": false, "description": "100 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-31)", "package_ndc": "62332-095-31", "marketing_start_date": "20140411"}, {"sample": false, "description": "1000 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-095-91)", "package_ndc": "62332-095-91", "marketing_start_date": "20140411"}], "brand_name": "lamotrigine", "product_id": "62332-095_8b09deb8-500f-428a-b588-6a238c7c553c", "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": "62332-095", "generic_name": "lamotrigine", "labeler_name": "Alembic Pharmaceuticals Inc.", "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": "20140411", "listing_expiration_date": "20271231"}