lamotrigine

Generic: lamotrigine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 25 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1469
Product ID 71335-1469_917573a6-61bf-4b9c-8eba-cc4c79935072
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200672
Listing Expiration 2026-12-31
Marketing Start 2016-04-01

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 713351469
Hyphenated Format 71335-1469

Supplemental Identifiers

RxCUI
900164
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 ANDA200672 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1469-1)
source: ndc

Packages (1)

71335-1469-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1469-1)

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": "917573a6-61bf-4b9c-8eba-cc4c79935072", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["900164"], "spl_set_id": ["36f383af-8b71-4875-85ef-3a7a8b1d8805"], "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": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1469-1)", "package_ndc": "71335-1469-1", "marketing_start_date": "20200110"}], "brand_name": "Lamotrigine", "product_id": "71335-1469_917573a6-61bf-4b9c-8eba-cc4c79935072", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "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": "71335-1469", "generic_name": "Lamotrigine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "25 mg/1"}], "application_number": "ANDA200672", "marketing_category": "ANDA", "marketing_start_date": "20160401", "listing_expiration_date": "20261231"}