lamotrigine

Generic: lamotrigine

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 25 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-339
Product ID 13668-339_aae9e98a-c9b3-4e3c-8e24-ff46f11bcadf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203370
Listing Expiration 2027-12-31
Marketing Start 2013-12-23

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 13668339
Hyphenated Format 13668-339

Supplemental Identifiers

RxCUI
850087 850091 900156 900164
UPC
0313668342307 0313668341300 0313668340303
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 ANDA203370 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-30)
source: ndc

Packages (3)

13668-339-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-01) 13668-339-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-05) 13668-339-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-30)

Ingredients (1)

lamotrigine (25 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": "aae9e98a-c9b3-4e3c-8e24-ff46f11bcadf", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0313668342307", "0313668341300", "0313668340303"], "unii": ["U3H27498KS"], "rxcui": ["850087", "850091", "900156", "900164"], "spl_set_id": ["52df02a7-83da-4b20-9951-69790237dc24"], "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": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-01)", "package_ndc": "13668-339-01", "marketing_start_date": "20131223"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-05)", "package_ndc": "13668-339-05", "marketing_start_date": "20131223"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-30)", "package_ndc": "13668-339-30", "marketing_start_date": "20131223"}], "brand_name": "Lamotrigine", "product_id": "13668-339_aae9e98a-c9b3-4e3c-8e24-ff46f11bcadf", "dosage_form": "TABLET, 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": "13668-339", "generic_name": "Lamotrigine", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "25 mg/1"}], "application_number": "ANDA203370", "marketing_category": "ANDA", "marketing_start_date": "20131223", "listing_expiration_date": "20271231"}