Felbatol (felbamate) NDC 0037-0431

NDC codes

FDA NDC Directory

Product NDC (as listed)0037-0431Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00037-0431Add 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
0037-0431-01	00037043101	100 TABLET in 1 BOTTLE, PLASTIC (0037-0431-01)Marketed from Jul 29, 1993

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Felbatol
Generic name (nonproprietary): felbamate
Active ingredients: Felbamate — 600 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Viatris Specialty LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020189
Marketing start: Jul 29, 1993
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 0037-0431_374f8c69-4219-47fd-aeda-8edc73da5411SPL ID 374f8c69-4219-47fd-aeda-8edc73da5411SPL set ID 2f522701-397a-11de-8a39-0800200c9a66RxCUI 198358, 198359, 209026, 209027, 209028, 310285UNII X72RBB02N8
Pharmacologic class: Anti-epileptic Agent

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

N400037043101 followed by a unit qualifier and the quantity

Package 00037-0431-01. 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 Aug 15, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Felbatol ® is not indicated as a first line antiepileptic treatment (see Warnings ). Felbatol ® is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk and has provided written acknowledgment, Felbatol ® can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020189

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

FDA NDC Directory listings under NDA 020189
Product	Strength	Form · route	Labeler	Product NDC
Felbatolfelbamate	Felbamate 400 mg/1	TabletOral	Viatris Specialty LLC	0037-0430