lamotrigine

Generic: lamotrigine extended-release

Labeler: yiling pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine extended-release
Labeler yiling pharmaceutical, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 100 mg/1

Manufacturer
Yiling Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 69117-0046
Product ID 69117-0046_47239426-3d75-73d8-e063-6294a90a608d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213949
Listing Expiration 2026-12-31
Marketing Start 2021-12-09

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 691170046
Hyphenated Format 69117-0046

Supplemental Identifiers

RxCUI
850087 850091 900156 900164 1098608 1146690
UPC
0369117004920 0369117004739 0369117004517 0369117004913 0369117004425 0369117004722 0369117004838 0369117004418 0369117004616 0369117004623 0369117004715 0369117004432 0369117004524 0369117004814 0369117004821 0369117004630 0369117004937 0369117004531
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 extended-release (source: ndc)
Application Number ANDA213949 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0046-1)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0046-2)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0046-3)
source: ndc

Packages (3)

69117-0046-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0046-1) 69117-0046-2 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0046-2) 69117-0046-3 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0046-3)

Ingredients (1)

lamotrigine (100 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": "47239426-3d75-73d8-e063-6294a90a608d", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0369117004920", "0369117004739", "0369117004517", "0369117004913", "0369117004425", "0369117004722", "0369117004838", "0369117004418", "0369117004616", "0369117004623", "0369117004715", "0369117004432", "0369117004524", "0369117004814", "0369117004821", "0369117004630", "0369117004937", "0369117004531"], "unii": ["U3H27498KS"], "rxcui": ["850087", "850091", "900156", "900164", "1098608", "1146690"], "spl_set_id": ["f7de11a5-5357-4753-b1ac-b15123b50028"], "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": ["Yiling Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0046-1)", "package_ndc": "69117-0046-1", "marketing_start_date": "20211209"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0046-2)", "package_ndc": "69117-0046-2", "marketing_start_date": "20211209"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69117-0046-3)", "package_ndc": "69117-0046-3", "marketing_start_date": "20211209"}], "brand_name": "lamotrigine", "product_id": "69117-0046_47239426-3d75-73d8-e063-6294a90a608d", "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": "69117-0046", "generic_name": "lamotrigine extended-release", "labeler_name": "Yiling Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "100 mg/1"}], "application_number": "ANDA213949", "marketing_category": "ANDA", "marketing_start_date": "20211209", "listing_expiration_date": "20261231"}