Lamotrigine NDC 0228-1638

NDC codes

FDA NDC Directory

Product NDC (as listed)0228-1638Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00228-1638Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0228-1638-03	00228163803	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1638-03)Marketed from Jun 1, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Lamotrigine
Generic name (nonproprietary): lamotrigine
Active ingredients: Lamotrigine — 250 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200672
Marketing start: Jun 1, 2016
Listing expires: Dec 31, 2027
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 0228-1638_49ac5dcd-9ccd-4e5a-9fdd-fe22a79c2770SPL ID 49ac5dcd-9ccd-4e5a-9fdd-fe22a79c2770SPL set ID 87beaf22-593d-4170-bb58-332c615ef90dRxCUI 850087, 850091, 900156, 900164, 1098608, 1146690UNII U3H27498KSUPC 0302281410036, 0302281435039
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

N400228163803 followed by a unit qualifier and the quantity

Package 00228-1638-03. 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

Current FDA label (SPL), effective Apr 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine extended-release tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1 ) conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2 ) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. ( 1.3 ) 1.1 Adjunctive Therapy Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200672

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

FDA NDC Directory listings under ANDA 200672
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 300 mg/1	Tablet, Film coated, Extended releaseOral	Actavis Pharma, Inc.	0228-1580
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-1469
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Film coated, Extended releaseOral	Actavis Pharma, Inc.	0228-1422
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Film coated, Extended releaseOral	Actavis Pharma, Inc.	0228-1453