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 KIT
Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-266
Product ID 13668-266_e20d1c8d-dadf-4a54-8f0c-4ce62087f2e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078947
Listing Expiration 2027-12-31
Marketing Start 2009-01-27

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 13668266
Hyphenated Format 13668-266

Supplemental Identifiers

RxCUI
198427 198428 198429 282401 751139 751563 753451
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 ANDA078947 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 25 mg
  • 100 mg
  • 150 mg
  • 200 mg
  • 10 unit
source: label
Packaging
  • 14 BLISTER PACK in 1 PACKAGE, COMBINATION (13668-266-28) / 1 KIT in 1 BLISTER PACK
  • 7 BLISTER PACK in 1 PACKAGE, COMBINATION (13668-266-99) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (2)

13668-266-28 14 BLISTER PACK in 1 PACKAGE, COMBINATION (13668-266-28) / 1 KIT in 1 BLISTER PACK 13668-266-99 7 BLISTER PACK in 1 PACKAGE, COMBINATION (13668-266-99) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

LAMOTRIGINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "e20d1c8d-dadf-4a54-8f0c-4ce62087f2e2", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "282401", "751139", "751563", "753451"], "spl_set_id": ["3448839b-4933-4ef9-a80a-9e504d2c5696"], "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": "14 BLISTER PACK in 1 PACKAGE, COMBINATION (13668-266-28)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "13668-266-28", "marketing_start_date": "20090127"}, {"sample": false, "description": "7 BLISTER PACK in 1 PACKAGE, COMBINATION (13668-266-99)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "13668-266-99", "marketing_start_date": "20090127"}], "brand_name": "LAMOTRIGINE", "product_id": "13668-266_e20d1c8d-dadf-4a54-8f0c-4ce62087f2e2", "dosage_form": "KIT", "product_ndc": "13668-266", "generic_name": "lamotrigine", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LAMOTRIGINE", "application_number": "ANDA078947", "marketing_category": "ANDA", "marketing_start_date": "20090127", "listing_expiration_date": "20271231"}