Felbamate NDC 70954-051

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-051Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0051Add 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
70954-051-10	70954005110	237 mL in 1 BOTTLE (70954-051-10)Marketed from Jul 15, 2022
70954-051-20	70954005120	473 mL in 1 BOTTLE (70954-051-20)Marketed from Jul 15, 2022

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): Felbamate
Generic name (nonproprietary): felbamate
Active ingredients: Felbamate — 600 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Novitium Pharma LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211333
Marketing start: Jul 15, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 70954-051_ca7073d4-4e4c-48b5-892a-2c33fa54062dSPL ID ca7073d4-4e4c-48b5-892a-2c33fa54062dSPL set ID 81c8a2e1-732c-4467-84e9-53fef1655ee2RxCUI 310285UNII X72RBB02N8UPC 0370954051107, 0370954051206
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

N470954005110 followed by a unit qualifier and the quantity

Package 70954-0051-10. 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 Sep 13, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Felbamate oral suspension is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate oral suspension 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 acknowledgement, felbamate oral suspension can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults wit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)