What is NDC 65162-686?

65162-686 is the product NDC for Felbamate, Felbamate 600 mg/5mL suspension, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Felbamate?

19 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Felbamate NDC 65162-686 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-686Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0686Add 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
65162-686-88	6516206868865162068688	237 mL in 1 BOTTLE (65162-686-88)Marketed from Dec 16, 2011
65162-686-90	6516206869065162068690	473 mL in 1 BOTTLE (65162-686-90)Marketed from Dec 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 — 600 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202385
Marketing start: Dec 16, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 65162-686_5ae2c0c1-5f34-4c23-bb17-169302c2253fSPL ID 5ae2c0c1-5f34-4c23-bb17-169302c2253fSPL set ID 2e325d79-d0a4-4af7-b09b-96ee5a5b2a37RxCUI 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

N465162068688 followed by a unit qualifier and the quantity

Package 65162-0686-88. 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 24, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND 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 acknowledgment, felbamate oral suspension can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-686

What is NDC 65162-686?: 65162-686 is the product NDC for Felbamate, Felbamate 600 mg/5mL suspension, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Felbamate.
What is the active ingredient?: Felbamate.
Who is the labeler?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Felbamate?: 19 other product NDCs are listed under this name. See all Felbamate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Felbamate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Felbamate	Felbamate 400 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-734	53746-0734-3053746-0734-90
Felbamate	Felbamate 600 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-735	53746-0735-1853746-0735-3053746-0735-90
Felbamate	Felbamate 600 mg/5mL	SuspensionOral	Novitium Pharma LLC	70954-051	70954-0051-1070954-0051-20
Felbamate	Felbamate 400 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-056	72578-0056-0172578-0056-0572578-0056-06+2 more
Felbamate	Felbamate 600 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-057	72578-0057-0172578-0057-0572578-0057-06+3 more
Felbamate	Felbamate 400 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-730	62559-0730-01
Felbamate	Felbamate 600 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-731	62559-0731-01
Felbamate	Felbamate 400 mg/1	TabletOral	Bryant Ranch Prepack	63629-1937	63629-1937-01
Felbamate	Felbamate 600 mg/1	TabletOral	Bryant Ranch Prepack	63629-1944	63629-1944-01
Felbamate	Felbamate 400 mg/1	TabletOral	Bryant Ranch Prepack	72162-1770	72162-1770-01

All 20 Felbamate NDCs