lamotrigine

Generic: lamotrigine

Labeler: nordic pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler nordic pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 100 mg/1

Manufacturer
Nordic Pharma, Inc.

Identifiers & Regulatory

Product NDC 69918-370
Product ID 69918-370_3e1dd650-3c58-44f0-be26-8a7de4cedec5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214124
Listing Expiration 2026-12-31
Marketing Start 2022-02-14

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 69918370
Hyphenated Format 69918-370

Supplemental Identifiers

RxCUI
103968 198430 252478 252479
UPC
0369918360300 0369918380308 0369918350301
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 ANDA214124 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69918-370-30)
source: ndc

Packages (1)

69918-370-30 30 TABLET in 1 BOTTLE (69918-370-30)

Ingredients (1)

lamotrigine (100 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": "3e1dd650-3c58-44f0-be26-8a7de4cedec5", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0369918360300", "0369918380308", "0369918350301"], "unii": ["U3H27498KS"], "rxcui": ["103968", "198430", "252478", "252479"], "spl_set_id": ["67cf961e-02b9-4a99-944f-43a55df6a544"], "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": ["Nordic Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69918-370-30)", "package_ndc": "69918-370-30", "marketing_start_date": "20220214"}], "brand_name": "Lamotrigine", "product_id": "69918-370_3e1dd650-3c58-44f0-be26-8a7de4cedec5", "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": "69918-370", "generic_name": "Lamotrigine", "labeler_name": "Nordic Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "100 mg/1"}], "application_number": "ANDA214124", "marketing_category": "ANDA", "marketing_start_date": "20220214", "listing_expiration_date": "20261231"}