lamotrigine

Generic: lamotrigine

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

Drug Facts

Product Profile

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

lamotrigine 100 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-038
Product ID 62332-038_3a44ccc7-087b-4201-a4ea-2d9c9b3195b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090607
Listing Expiration 2027-12-31
Marketing Start 2018-02-05

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 62332038
Hyphenated Format 62332-038

Supplemental Identifiers

RxCUI
198427 198428 198429 282401
UPC
0362332039302 0362332040308 0362332038305
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 ANDA090607 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62332-038-30)
  • 100 TABLET in 1 BOTTLE (62332-038-31)
  • 500 TABLET in 1 BOTTLE (62332-038-71)
  • 1000 TABLET in 1 BOTTLE (62332-038-91)
source: ndc

Packages (4)

62332-038-30 30 TABLET in 1 BOTTLE (62332-038-30) 62332-038-31 100 TABLET in 1 BOTTLE (62332-038-31) 62332-038-71 500 TABLET in 1 BOTTLE (62332-038-71) 62332-038-91 1000 TABLET in 1 BOTTLE (62332-038-91)

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": "3a44ccc7-087b-4201-a4ea-2d9c9b3195b3", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0362332039302", "0362332040308", "0362332038305"], "unii": ["U3H27498KS"], "rxcui": ["198427", "198428", "198429", "282401"], "spl_set_id": ["60958229-5b5f-49e2-97f4-a8722138f7ce"], "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": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62332-038-30)", "package_ndc": "62332-038-30", "marketing_start_date": "20180205"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (62332-038-31)", "package_ndc": "62332-038-31", "marketing_start_date": "20180205"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (62332-038-71)", "package_ndc": "62332-038-71", "marketing_start_date": "20180205"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (62332-038-91)", "package_ndc": "62332-038-91", "marketing_start_date": "20180205"}], "brand_name": "Lamotrigine", "product_id": "62332-038_3a44ccc7-087b-4201-a4ea-2d9c9b3195b3", "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": "62332-038", "generic_name": "Lamotrigine", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "100 mg/1"}], "application_number": "ANDA090607", "marketing_category": "ANDA", "marketing_start_date": "20180205", "listing_expiration_date": "20271231"}