Lamotrigine NDC 42291-367

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-367Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0367Add 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
42291-367-01	42291036701	100 TABLET in 1 BOTTLE (42291-367-01)Marketed from Apr 10, 2013
42291-367-10	42291036710	1000 TABLET in 1 BOTTLE (42291-367-10)Marketed from Jan 28, 2015

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
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079132
Marketing start: Apr 10, 2013
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 42291-367_51b57ded-2d7d-d540-e063-6394a90a4744SPL ID 51b57ded-2d7d-d540-e063-6394a90a4744SPL set ID fcdb94a8-33be-6375-98ef-6933999d157fRxCUI 198427, 198428, 198429, 282401UNII U3H27498KSUPC 0342291368606
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

N442291036701 followed by a unit qualifier and the quantity

Package 42291-0367-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 079132

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

FDA NDC Directory listings under ANDA 079132
Product	Strength	Form · route	Labeler	Product NDC
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	AvKARE	42291-366
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Bryant Ranch Prepack	63629-4697
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	AvKARE	42291-368
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	AvKARE	42291-369
Lamotrigine	Lamotrigine 150 mg/1	TabletOral	Jubilant Cadista Pharmacuticals Inc.	59746-247
Lamotrigine	Lamotrigine 25 mg/1	TabletOral	Jubilant Cadista Pharmacuticals Inc.	59746-245
Lamotrigine	Lamotrigine 100 mg/1	TabletOral	Jubilant Cadista Pharmacuticals Inc.	59746-246
Lamotrigine	Lamotrigine 200 mg/1	TabletOral	Jubilant Cadista Pharmacuticals Inc.	59746-248