Lamotrigine NDC 55111-419

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-419Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0419Add 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
55111-419-05	55111041905	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-419-05)Marketed from Sep 6, 2018
55111-419-30	55111041930	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-419-30)Marketed from Sep 6, 2018
55111-419-90	55111041990	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-419-90)Marketed from Sep 6, 2018

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 — 250 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Dr.Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202383
Marketing start: Sep 6, 2018
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 55111-419_236437dc-fce9-b140-992c-b7822562eee5SPL ID 236437dc-fce9-b140-992c-b7822562eee5SPL set ID a69542ea-5b6f-15c1-9e7a-90ac839971d3RxCUI 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

N455111041905 followed by a unit qualifier and the quantity

Package 55111-0419-05. 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 21, 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 and partial-onset (PGTC) 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 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 200 mg/1	Tablet, Extended releaseOral	NorthStar Rx LLC	16714-626
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