lamotrigine

Generic: lamotrigine

Labeler: northstar rx llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler northstar rx llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 150 mg/1

Manufacturer
Northstar Rx LLC.

Identifiers & Regulatory

Product NDC 16714-196
Product ID 16714-196_f6d6f71c-c94d-4bde-ac57-850998dad74f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077633
Listing Expiration 2027-12-31
Marketing Start 2021-11-17

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 16714196
Hyphenated Format 16714-196

Supplemental Identifiers

RxCUI
198427 198428 198429 282401
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 ANDA077633 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (16714-196-01)
source: ndc

Packages (1)

16714-196-01 60 TABLET in 1 BOTTLE (16714-196-01)

Ingredients (1)

lamotrigine (150 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": "f6d6f71c-c94d-4bde-ac57-850998dad74f", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "282401"], "spl_set_id": ["aabc64fe-1f17-4140-81f2-7d4506db6c8b"], "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": ["Northstar Rx LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (16714-196-01)", "package_ndc": "16714-196-01", "marketing_start_date": "20211117"}], "brand_name": "Lamotrigine", "product_id": "16714-196_f6d6f71c-c94d-4bde-ac57-850998dad74f", "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": "16714-196", "generic_name": "Lamotrigine", "labeler_name": "Northstar Rx LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "150 mg/1"}], "application_number": "ANDA077633", "marketing_category": "ANDA", "marketing_start_date": "20211117", "listing_expiration_date": "20271231"}