NDC codes

FDA NDC Directory
Product NDC (as listed)27241-185Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27241-0185Add 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 NDC11-digit (billing)PackageCopy
27241-185-302724101853030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-185-30)Marketed from Jan 19, 2021

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 — 100 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213271
Marketing start
Listing expires
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 27241-185_9791ac5c-7be4-4ff8-8de3-21ab21346ca9SPL ID 9791ac5c-7be4-4ff8-8de3-21ab21346ca9SPL set ID 9dfb5f87-0150-4c26-a89f-34f1ab389500RxCUI 103968, 198430, 252478, 252479UNII U3H27498KSUPC 0327241184307, 0327241186301, 0327241183300, 0327241185304
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

N427241018530 followed by a unit qualifier and the quantity

Package 27241-0185-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Lamotrigine orally disintegrating 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. ( …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213271

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

FDA NDC Directory listings under ANDA 213271
ProductStrengthForm · routeLabelerProduct NDC
LamotrigineLamotrigine 25 mg/1Tablet, Orally disintegratingOralAjanta Pharma USA Inc.27241-183
LamotrigineLamotrigine 50 mg/1Tablet, Orally disintegratingOralAjanta Pharma USA Inc.27241-184
LamotrigineLamotrigine 200 mg/1Tablet, Orally disintegratingOralAjanta Pharma USA Inc.27241-186

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Lamotrigine NDC 27241-185 | Med-Code