What is NDC 53746-734?

53746-734 is the product NDC for Felbamate, Felbamate 400 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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 53746-734 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-734Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0734Add 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	Copy
53746-734-30	53746073430	30 TABLET in 1 BOTTLE (53746-734-30)Marketed from Aug 10, 2022
53746-734-90	53746073490	90 TABLET in 1 BOTTLE (53746-734-90)Marketed from Aug 10, 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 — 400 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201680
Marketing start: Aug 10, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 53746-734_79c0fbe1-55e9-4bac-83e1-5d9e0a1f4df9SPL ID 79c0fbe1-55e9-4bac-83e1-5d9e0a1f4df9SPL set ID 1aa40de5-c02d-49d6-8722-ed88c40c3ba6RxCUI 198358, 198359UNII X72RBB02N8UPC 0353746735300
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

N453746073430 followed by a unit qualifier and the quantity

Package 53746-0734-30. 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 Apr 6, 2026. 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 acknowledgement, 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 epi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-734

What is NDC 53746-734?: 53746-734 is the product NDC for Felbamate, Felbamate 400 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York 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 of New York LLC, NDC labeler code 53746. 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 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 600 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-057	72578-0057-0172578-0057-0572578-0057-06+3 more
Felbamate	Felbamate 400 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-056	72578-0056-0172578-0056-0572578-0056-06+2 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 600 mg/1	TabletOral	Bryant Ranch Prepack	72162-1771	72162-1771-01
Felbamate	Felbamate 400 mg/1	TabletOral	Bryant Ranch Prepack	72162-1770	72162-1770-01

All 20 Felbamate NDCs

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 LLC	65162-734
Felbamate	Felbamate 600 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-735