Aptiom (eslicarbazepine acetate) NDC 63402-208

NDC codes

FDA NDC Directory

Product NDC (as listed)63402-208Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63402-0208Add 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
63402-208-28	63402020828	4 BLISTER PACK in 1 CARTON (63402-208-28) / 7 TABLET in 1 BLISTER PACK (63402-208-07)Marketed from Apr 7, 2014
63402-208-30	63402020830	30 TABLET in 1 BOTTLE (63402-208-30)Marketed from Apr 7, 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): Aptiom
Generic name (nonproprietary): eslicarbazepine acetate
Active ingredients: Eslicarbazepine acetate — 800 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sumitomo Pharma America, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022416
Marketing start: Apr 7, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 63402-208_3af99c5d-50e2-4336-8a5e-e93b6cf3618aSPL ID 3af99c5d-50e2-4336-8a5e-e93b6cf3618aSPL set ID 3d0c9554-eaeb-4694-8089-00133fcadce3RxCUI 1482507, 1482513, 1482515, 1482517, 1482521, 1482523, 1482525, 1482527, 1491642, 1491643UNII BEA68ZVB2K

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

N463402020828 followed by a unit qualifier and the quantity

Package 63402-0208-28. 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 10, 2023.

Indications (excerpt from the label)

APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022416

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

FDA NDC Directory listings under NDA 022416
Product	Strength	Form · route	Labeler	Product NDC
Aptiomeslicarbazepine acetate	Eslicarbazepine acetate 400 mg/1	TabletOral	Sumitomo Pharma America, Inc.	63402-204
Aptiomeslicarbazepine acetate	Eslicarbazepine acetate 200 mg/1	TabletOral	Sumitomo Pharma America, Inc.	63402-202
Aptiomeslicarbazepine acetate	Eslicarbazepine acetate 600 mg/1	TabletOral	Sumitomo Pharma America, Inc.	63402-206
Aptiomeslicarbazepine acetate	—	KitOral	Sumitomo Pharma America, Inc.	63402-248