Lamictal XR (lamotrigine) NDC 0173-0761

NDC codes

FDA NDC Directory

Product NDC (as listed)0173-0761Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00173-0761Add 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
0173-0761-00	00173076100	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0761-00)Marketed from Mar 31, 2011

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): Lamictal XRSuffix: XR
Generic name (nonproprietary): lamotrigine
Active ingredients: Lamotrigine — 300 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: GlaxoSmithKline LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022115
Marketing start: Mar 31, 2011
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 0173-0761_d0cca76f-809f-4db8-a468-619a217debc1SPL ID d0cca76f-809f-4db8-a468-619a217debc1SPL set ID 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09RxCUI 850087, 850091, 900145, 900156, 900157, 900164, 900165, 900169, 900865, 900866, 900890, 900891, 900983, 900984, 1098608, 1098610, 1146690, 1146692UNII U3H27498KSUPC 0301730756008, 0301730757005, 0301730761002, 0301730754004, 0301730781000
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

N400173076100 followed by a unit qualifier and the quantity

Package 00173-0761-00. 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 Oct 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

LAMICTAL XR is 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 LAMICTAL XR is indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022115

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

FDA NDC Directory listings under NDA 022115
Product	Strength	Form · route	Labeler	Product NDC
Lamictal XRlamotrigine	—	Kit	GlaxoSmithKline LLC	0173-0759
Lamictal XRlamotrigine	—	Kit	GlaxoSmithKline LLC	0173-0760
Lamictal XRlamotrigine	Lamotrigine 250 mg/1	Tablet, Film coated, Extended releaseOral	GlaxoSmithKline LLC	0173-0781
Lamictal XRlamotrigine	Lamotrigine 25 mg/1	Tablet, Film coated, Extended releaseOral	GlaxoSmithKline LLC	0173-0754
Lamictal XRlamotrigine	Lamotrigine 50 mg/1	Tablet, Film coated, Extended releaseOral	GlaxoSmithKline LLC	0173-0755
Lamictal XRlamotrigine	Lamotrigine 100 mg/1	Tablet, Film coated, Extended releaseOral	GlaxoSmithKline LLC	0173-0756
Lamictal XRlamotrigine	Lamotrigine 200 mg/1	Tablet, Film coated, Extended releaseOral	GlaxoSmithKline LLC	0173-0757
Lamictal XRlamotrigine	—	Kit	GlaxoSmithKline LLC	0173-0758