Lamotrigine NDC 16714-626

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-626Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0626Add 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
16714-626-01	16714062601	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-626-01)Marketed from Jun 20, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 200 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: NorthStar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202383
Marketing start: Jun 20, 2017
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 16714-626_77f5183c-b6b1-c8e4-2757-8d318ea6cf9dSPL ID 77f5183c-b6b1-c8e4-2757-8d318ea6cf9dSPL set ID 9ab07d6b-ae4a-a310-5572-b266676cd29eRxCUI 850087, 850091, 900156, 900164, 1098608, 1146690UNII 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

N416714062601 followed by a unit qualifier and the quantity

Package 16714-0626-01. 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 Nov 20, 2025. 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 or wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202383

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

FDA NDC Directory listings under ANDA 202383
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 250 mg/1	Tablet, Extended releaseOral	NorthStar Rx LLC	16714-893
Lamotrigine	Lamotrigine 250 mg/1	Tablet, Extended releaseOral	Dr.Reddy's Laboratories Limited	55111-419
Lamotrigine	Lamotrigine 300 mg/1	Tablet, Extended releaseOral	Dr.Reddy's Laboratories Limited	55111-428
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4121
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Extended releaseOral	NorthStar Rx LLC	16714-625
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Extended releaseOral	NorthStar Rx LLC	16714-623
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Extended releaseOral	NorthStar Rx LLC	16714-624
Lamotrigine	Lamotrigine 300 mg/1	Tablet, Extended releaseOral	NorthStar Rx LLC	16714-627
Lamotrigine	Lamotrigine 50 mg/1	Tablet, Extended releaseOral	Dr.Reddy's Laboratories Limited	55111-718
Lamotrigine	Lamotrigine 25 mg/1	Tablet, Extended releaseOral	Dr.Reddy's Laboratories Limited	55111-717
Lamotrigine	Lamotrigine 100 mg/1	Tablet, Extended releaseOral	Dr.Reddy's Laboratories Limited	55111-719
Lamotrigine	Lamotrigine 200 mg/1	Tablet, Extended releaseOral	Dr.Reddy's Laboratories Limited	55111-720