lamotrigine

Generic: lamotrigine

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lamotrigine 250 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-011
Product ID 68382-011_277200d5-a863-4411-8c1b-aac8d7fde6a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077633
Listing Expiration 2026-12-31
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 68382011
Hyphenated Format 68382-011

Supplemental Identifiers

RxCUI
198427 198428 198429 199322 249329 282401 311264 311265
UPC
0368382109019 0368382011053 0368382108012
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
  • 250 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (68382-011-05)
  • 60 TABLET in 1 BOTTLE (68382-011-14)
  • 90 TABLET in 1 BOTTLE (68382-011-16)
source: ndc

Packages (3)

68382-011-05 500 TABLET in 1 BOTTLE (68382-011-05) 68382-011-14 60 TABLET in 1 BOTTLE (68382-011-14) 68382-011-16 90 TABLET in 1 BOTTLE (68382-011-16)

Ingredients (1)

lamotrigine (250 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": "277200d5-a863-4411-8c1b-aac8d7fde6a6", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0368382109019", "0368382011053", "0368382108012"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "199322", "249329", "282401", "311264", "311265"], "spl_set_id": ["e849033b-a3bc-408e-88de-7cd1d2660949"], "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": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-011-05)", "package_ndc": "68382-011-05", "marketing_start_date": "20090127"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68382-011-14)", "package_ndc": "68382-011-14", "marketing_start_date": "20090127"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-011-16)", "package_ndc": "68382-011-16", "marketing_start_date": "20090127"}], "brand_name": "Lamotrigine", "product_id": "68382-011_277200d5-a863-4411-8c1b-aac8d7fde6a6", "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": "68382-011", "generic_name": "Lamotrigine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "250 mg/1"}], "application_number": "ANDA077633", "marketing_category": "ANDA", "marketing_start_date": "20090127", "listing_expiration_date": "20261231"}