lamotrigine

Generic: lamotrigine

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

Drug Facts

Product Profile

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

lamotrigine 150 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1978
Product ID 70518-1978_498b82e4-2410-95ef-e063-6394a90a0322
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090170
Listing Expiration 2027-12-31
Marketing Start 2019-03-25

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 705181978
Hyphenated Format 70518-1978

Supplemental Identifiers

RxCUI
198428
UNII
U3H27498KS
NUI
N0000175753 N0000008486 N0000175751 N0000187061 N0000000191

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 ANDA090170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-1978-0)
source: ndc

Packages (1)

70518-1978-0 30 TABLET in 1 BLISTER PACK (70518-1978-0)

Ingredients (1)

lamotrigine (150 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": "498b82e4-2410-95ef-e063-6394a90a0322", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "unii": ["U3H27498KS"], "rxcui": ["198428"], "spl_set_id": ["811188be-d231-4b58-8d7a-b01b236fab51"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-1978-0)", "package_ndc": "70518-1978-0", "marketing_start_date": "20190325"}], "brand_name": "Lamotrigine", "product_id": "70518-1978_498b82e4-2410-95ef-e063-6394a90a0322", "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": "70518-1978", "generic_name": "Lamotrigine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "150 mg/1"}], "application_number": "ANDA090170", "marketing_category": "ANDA", "marketing_start_date": "20190325", "listing_expiration_date": "20271231"}