subvenite

Generic: lamotrigine

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

Drug Facts

Product Profile

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

lamotrigine 10 mg/mL

Manufacturer
OWP Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 69102-418
Product ID 69102-418_2fc41672-1233-420d-be83-17165b23eea8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218879
Listing Expiration 2027-12-31
Marketing Start 2025-10-01

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 69102418
Hyphenated Format 69102-418

Supplemental Identifiers

RxCUI
2724462 2724466
UPC
0369102418015
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 NDA218879 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 PACKAGE (69102-418-01) / 240 mL in 1 BOTTLE
  • 2 BOTTLE in 1 PACKAGE (69102-418-02) / 240 mL in 1 BOTTLE
source: ndc

Packages (2)

69102-418-01 1 BOTTLE in 1 PACKAGE (69102-418-01) / 240 mL in 1 BOTTLE 69102-418-02 2 BOTTLE in 1 PACKAGE (69102-418-02) / 240 mL in 1 BOTTLE

Ingredients (1)

lamotrigine (10 mg/mL)

Linked Drug Pages (1)

SUBVENITE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2fc41672-1233-420d-be83-17165b23eea8", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0369102418015"], "unii": ["U3H27498KS"], "rxcui": ["2724462", "2724466"], "spl_set_id": ["022b0913-f683-4af8-a862-f81b315909b2"], "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": "1 BOTTLE in 1 PACKAGE (69102-418-01)  / 240 mL in 1 BOTTLE", "package_ndc": "69102-418-01", "marketing_start_date": "20251001"}, {"sample": false, "description": "2 BOTTLE in 1 PACKAGE (69102-418-02)  / 240 mL in 1 BOTTLE", "package_ndc": "69102-418-02", "marketing_start_date": "20251001"}], "brand_name": "SUBVENITE", "product_id": "69102-418_2fc41672-1233-420d-be83-17165b23eea8", "dosage_form": "SUSPENSION", "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": "69102-418", "generic_name": "LAMOTRIGINE", "labeler_name": "OWP Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SUBVENITE", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "10 mg/mL"}], "application_number": "NDA218879", "marketing_category": "NDA", "marketing_start_date": "20251001", "listing_expiration_date": "20271231"}