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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

lamotrigine 50 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-980
Product ID 68382-980_f4f7fc12-39cf-4974-80b3-d077e503bb90
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207763
Listing Expiration 2026-12-31
Marketing Start 2020-05-14

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 68382980
Hyphenated Format 68382-980

Supplemental Identifiers

RxCUI
850087 850091 900156 900164 1098608 1146690
UPC
0368382982063 0368382979063
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 ANDA207763 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-06)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-16)
source: ndc

Packages (3)

68382-980-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-05) 68382-980-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-06) 68382-980-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-16)

Ingredients (1)

lamotrigine (50 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": "f4f7fc12-39cf-4974-80b3-d077e503bb90", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0368382982063", "0368382979063"], "unii": ["U3H27498KS"], "rxcui": ["850087", "850091", "900156", "900164", "1098608", "1146690"], "spl_set_id": ["eb436371-d188-4803-a864-07b90c357e57"], "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, EXTENDED RELEASE in 1 BOTTLE (68382-980-05)", "package_ndc": "68382-980-05", "marketing_start_date": "20200514"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-06)", "package_ndc": "68382-980-06", "marketing_start_date": "20200514"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-980-16)", "package_ndc": "68382-980-16", "marketing_start_date": "20200514"}], "brand_name": "Lamotrigine", "product_id": "68382-980_f4f7fc12-39cf-4974-80b3-d077e503bb90", "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": "68382-980", "generic_name": "Lamotrigine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "50 mg/1"}], "application_number": "ANDA207763", "marketing_category": "ANDA", "marketing_start_date": "20200514", "listing_expiration_date": "20261231"}