NDC codes

FDA NDC Directory
Product NDC (as listed)62332-096Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0096Add 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
62332-096-306233200963030 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-096-30)Marketed from Apr 11, 2014
62332-096-3162332009631100 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-096-31)Marketed from Apr 11, 2014
62332-096-91623320096911000 TABLET, FOR SUSPENSION in 1 BOTTLE (62332-096-91)Marketed from Apr 11, 2014

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, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201168
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 62332-096_8b09deb8-500f-428a-b588-6a238c7c553cSPL ID 8b09deb8-500f-428a-b588-6a238c7c553cSPL set ID 05cba628-b12c-44d8-89a8-3522fe417cc1RxCUI 311264, 311265UNII U3H27498KSUPC 0362332096305, 0362332095308
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

N462332009630 followed by a unit qualifier and the quantity

Package 62332-0096-30. 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 is 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 o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201168

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

FDA NDC Directory listings under ANDA 201168
ProductStrengthForm · routeLabelerProduct NDC
lamotriginelamotrigine chewable dispersibleLamotrigine 5 mg/1Tablet, For suspensionOralAlembic Pharmaceuticals Limited46708-095
lamotriginelamotrigine chewable dispersibleLamotrigine 25 mg/1Tablet, For suspensionOralAlembic Pharmaceuticals Limited46708-096
lamotrigineLamotrigine 5 mg/1Tablet, For suspensionOralAlembic Pharmaceuticals Inc.62332-095

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