lamotrigine kit

Generic: lamotrigine

Labeler: owp pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine kit
Generic Name lamotrigine
Labeler owp pharmaceuticals, inc.
Dosage Form KIT
Manufacturer
OWP Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 69102-359
Product ID 69102-359_f193d1ef-b995-4952-90dd-f2c1c0df3480
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078947
Listing Expiration 2026-12-31
Marketing Start 2017-08-30

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 69102359
Hyphenated Format 69102-359

Supplemental Identifiers

RxCUI
198427 282401 751139 751563 753451
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 kit (source: ndc)
Generic Name lamotrigine (source: ndc)
Application Number ANDA078947 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 25 mg
  • 100 mg
source: label
Packaging
  • 14 BLISTER PACK in 1 PACKAGE, COMBINATION (69102-359-11) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

69102-359-11 14 BLISTER PACK in 1 PACKAGE, COMBINATION (69102-359-11) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

LAMOTRIGINE Kit, LAMOTRIGINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "f193d1ef-b995-4952-90dd-f2c1c0df3480", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["198427", "282401", "751139", "751563", "753451"], "spl_set_id": ["474fb321-575c-4b97-9dbe-080061652ee4"], "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": ["OWP Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 BLISTER PACK in 1 PACKAGE, COMBINATION (69102-359-11)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "69102-359-11", "marketing_start_date": "20170830"}], "brand_name": "LAMOTRIGINE Kit", "product_id": "69102-359_f193d1ef-b995-4952-90dd-f2c1c0df3480", "dosage_form": "KIT", "product_ndc": "69102-359", "generic_name": "LAMOTRIGINE", "labeler_name": "OWP Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LAMOTRIGINE", "brand_name_suffix": "Kit", "application_number": "ANDA078947", "marketing_category": "ANDA", "marketing_start_date": "20170830", "listing_expiration_date": "20261231"}