lamotrigine

Generic: lamotrigine

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 200 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3914
Product ID 50090-3914_8b0c2f2c-d0f4-4fe4-9f02-d56bcad9a858
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090170
Listing Expiration 2026-12-31
Marketing Start 2011-11-01

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 500903914
Hyphenated Format 50090-3914

Supplemental Identifiers

RxCUI
198429
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 ANDA090170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (50090-3914-0)
source: ndc

Packages (1)

50090-3914-0 60 TABLET in 1 BOTTLE (50090-3914-0)

Ingredients (1)

lamotrigine (200 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": "8b0c2f2c-d0f4-4fe4-9f02-d56bcad9a858", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["198429"], "spl_set_id": ["84277e2c-370c-4510-92bc-ef33a4a0f508"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (50090-3914-0)", "package_ndc": "50090-3914-0", "marketing_start_date": "20181206"}], "brand_name": "Lamotrigine", "product_id": "50090-3914_8b0c2f2c-d0f4-4fe4-9f02-d56bcad9a858", "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": "50090-3914", "generic_name": "Lamotrigine", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "200 mg/1"}], "application_number": "ANDA090170", "marketing_category": "ANDA", "marketing_start_date": "20111101", "listing_expiration_date": "20261231"}