subvenite

Generic: lamotrigine

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

Drug Facts

Product Profile

Brand Name subvenite
Generic Name lamotrigine
Labeler owp pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 100 mg/1

Manufacturer
OWP Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 69102-319
Product ID 69102-319_dc973c32-37d9-437d-8053-cbf96b9f20cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078947
Listing Expiration 2026-12-31
Marketing Start 2018-03-10

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 69102319
Hyphenated Format 69102-319

Supplemental Identifiers

RxCUI
198427 198428 198429 282401 751139 751563 753451 2001506 2001508 2003796 2003797 2003798 2003799 2003801
UPC
0369102150069 0369102319015 0369102320011 0369102301010
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 subvenite (source: ndc)
Generic Name lamotrigine (source: ndc)
Application Number ANDA078947 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69102-319-01)
  • 2500 TABLET in 1 BOTTLE (69102-319-02)
source: ndc

Packages (2)

69102-319-01 100 TABLET in 1 BOTTLE (69102-319-01) 69102-319-02 2500 TABLET in 1 BOTTLE (69102-319-02)

Ingredients (1)

lamotrigine (100 mg/1)

Linked Drug Pages (1)

SUBVENITE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dc973c32-37d9-437d-8053-cbf96b9f20cd", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0369102150069", "0369102319015", "0369102320011", "0369102301010"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "282401", "751139", "751563", "753451", "2001506", "2001508", "2003796", "2003797", "2003798", "2003799", "2003801"], "spl_set_id": ["7ad18b68-ba16-4810-9c3e-27fa970454e8"], "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": "100 TABLET in 1 BOTTLE (69102-319-01)", "package_ndc": "69102-319-01", "marketing_start_date": "20180310"}, {"sample": false, "description": "2500 TABLET in 1 BOTTLE (69102-319-02)", "package_ndc": "69102-319-02", "marketing_start_date": "20180310"}], "brand_name": "SUBVENITE", "product_id": "69102-319_dc973c32-37d9-437d-8053-cbf96b9f20cd", "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": "69102-319", "generic_name": "LAMOTRIGINE", "labeler_name": "OWP Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SUBVENITE", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "100 mg/1"}], "application_number": "ANDA078947", "marketing_category": "ANDA", "marketing_start_date": "20180310", "listing_expiration_date": "20261231"}