Lamotrigine NDC 70518-3043

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-3043Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-3043Add 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
70518-3043-1	70518304301	30 TABLET in 1 BLISTER PACK (70518-3043-1)Marketed from Jan 29, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078956
Marketing start: Mar 10, 2021
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 70518-3043_56cd8606-57ea-d9e9-e063-6294a90a45bbSPL ID 56cd8606-57ea-d9e9-e063-6294a90a45bbSPL set ID 6ef17301-6c0b-4941-a84d-12243875d2e2RxCUI 282401UNII U3H27498KS
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

N470518304301 followed by a unit qualifier and the quantity

Package 70518-3043-01. 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 Jul 17, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078956

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

FDA NDC Directory listings under ANDA 078956
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Aurobindo Pharma Limited	65862-228
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Aurobindo Pharma Limited	65862-229
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	Aurobindo Pharma Limited	65862-230
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Aurobindo Pharma Limited	65862-227
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Coupler LLC	67046-1573