lamotrigine

Generic: lamotrigine

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler endo usa, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

lamotrigine 50 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-485
Product ID 49884-485_9bb82767-a8f0-4956-875f-3d89731e1049
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204158
Listing Expiration 2026-12-31
Marketing Start 2015-12-16

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 49884485
Hyphenated Format 49884-485

Supplemental Identifiers

RxCUI
103968 198430 252478 252479 851748 851750 851752
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 ANDA204158 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (49884-485-11)
source: ndc

Packages (1)

49884-485-11 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (49884-485-11)

Ingredients (1)

lamotrigine (50 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": "9bb82767-a8f0-4956-875f-3d89731e1049", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["103968", "198430", "252478", "252479", "851748", "851750", "851752"], "spl_set_id": ["003663e5-c0c7-4fc1-a64d-313f2a5b10d2"], "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": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK (49884-485-11)", "package_ndc": "49884-485-11", "marketing_start_date": "20151216"}], "brand_name": "Lamotrigine", "product_id": "49884-485_9bb82767-a8f0-4956-875f-3d89731e1049", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "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": "49884-485", "generic_name": "Lamotrigine", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "50 mg/1"}], "application_number": "ANDA204158", "marketing_category": "ANDA", "marketing_start_date": "20151216", "listing_expiration_date": "20261231"}