Felbamate NDC 65162-734

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-734Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0734Add 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
65162-734-03	65162073403	30 TABLET in 1 BOTTLE (65162-734-03)Marketed from Sep 16, 2011
65162-734-09	65162073409	90 TABLET in 1 BOTTLE (65162-734-09)Marketed from Sep 16, 2011
65162-734-27	65162073427	270 TABLET in 1 BOTTLE (65162-734-27)Marketed from Sep 16, 2011
65162-734-50	65162073450	500 TABLET in 1 BOTTLE (65162-734-50)Marketed from Sep 16, 2011

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 — 400 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201680
Marketing start: Sep 16, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 65162-734_28bca98d-c89a-492a-a3e5-405098e33919SPL ID 28bca98d-c89a-492a-a3e5-405098e33919SPL set ID aa3fd2c0-98d6-45f3-81b0-a902526214c6RxCUI 198358, 198359UNII 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

N465162073403 followed by a unit qualifier and the quantity

Package 65162-0734-03. 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 Oct 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate tablets, USP are 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, felbamate tablets, USP can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epil…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201680

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

FDA NDC Directory listings under ANDA 201680
Product	Strength	Form · route	Labeler	Product NDC
Felbamate	Felbamate 600 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-735
Felbamate	Felbamate 400 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-734
Felbamate	Felbamate 600 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-735