lamotrigine

Generic: lamotrigine

Labeler: st. mary's medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler st. mary's medical park pharmacy
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 25 mg/1

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-543
Product ID 60760-543_e55a9e50-61e8-2b3f-e053-2995a90a4b74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078525
Listing Expiration 2026-12-31
Marketing Start 2022-07-27

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 60760543
Hyphenated Format 60760-543

Supplemental Identifiers

RxCUI
282401
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 ANDA078525 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (60760-543-30)
source: ndc

Packages (1)

60760-543-30 30 TABLET in 1 BOTTLE, PLASTIC (60760-543-30)

Ingredients (1)

lamotrigine (25 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": "e55a9e50-61e8-2b3f-e053-2995a90a4b74", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["282401"], "spl_set_id": ["e55a986a-217f-678e-e053-2a95a90aa779"], "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": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (60760-543-30)", "package_ndc": "60760-543-30", "marketing_start_date": "20220727"}], "brand_name": "Lamotrigine", "product_id": "60760-543_e55a9e50-61e8-2b3f-e053-2995a90a4b74", "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": "60760-543", "generic_name": "Lamotrigine", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "25 mg/1"}], "application_number": "ANDA078525", "marketing_category": "ANDA", "marketing_start_date": "20220727", "listing_expiration_date": "20261231"}