Lamotrigine NDC 55111-226

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-226Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0226Add 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
55111-226-01	55111022601	100 TABLET, CHEWABLE in 1 BOTTLE (55111-226-01)Marketed from Jan 29, 2009
55111-226-05	55111022605	500 TABLET, CHEWABLE in 1 BOTTLE (55111-226-05)Marketed from Jan 29, 2009
55111-226-30	55111022630	30 TABLET, CHEWABLE in 1 BOTTLE (55111-226-30)Marketed from Jan 29, 2009
55111-226-60	55111022660	60 TABLET, CHEWABLE in 1 BOTTLE (55111-226-60)Marketed from Jan 29, 2009
55111-226-78	55111022678	10 BLISTER PACK in 1 CARTON (55111-226-78) / 10 TABLET, CHEWABLE in 1 BLISTER PACK (55111-226-79)Marketed from Jan 29, 2009

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 — 25 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Dr.Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076701
Marketing start: Jan 29, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 55111-226_2cd813df-d72b-9337-d6ae-139b729a5e75SPL ID 2cd813df-d72b-9337-d6ae-139b729a5e75SPL set ID e1a0da17-d67c-e44f-bd42-33c4009e4cddRxCUI 311264, 311265UNII 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

N455111022601 followed by a unit qualifier and the quantity

Package 55111-0226-01. 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 Dec 10, 2018. This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine tablet (chewable, dispersible) is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older partial-onset seizures. primary generalized tonic-clonic seizures. generalized seizures of Lennox-Gastaut syndrome. 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 AED. (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: Treatmen…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076701

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

FDA NDC Directory listings under ANDA 076701
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 5 mg/1	Tablet, ChewableOral	Dr.Reddy's Laboratories Limited	55111-225