lamotrigine (lamotrigine extended-release) NDC 82804-022

Product information

Brand name (proprietary)

lamotrigine

Generic name (nonproprietary)

lamotrigine extended-release

Active ingredients

Lamotrigine — 50 mg/1

Dosage form

Tablet, Film coated, Extended release

Route

Oral

Labeler

Proficient Rx LP

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 213949

Marketing start

Dec 9, 2021

Listing expires

Dec 31, 2026

Other FDA classes

Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)

Identifiers

Product ID 82804-022_39efe933-bfed-4a6a-b270-0883871c5186SPL ID 39efe933-bfed-4a6a-b270-0883871c5186SPL set ID 39efe933-bfed-4a6a-b270-0883871c5186RxCUI 850091UNII U3H27498KSUPC 0382804022304

Pharmacologic class

Anti-epileptic Agent; Mood Stabilizer

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N482804002230 followed by a unit qualifier and the quantity Copy

Package 82804-0022-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 213949

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.