What is NDC 16714-775?

16714-775 is the product NDC for Felbamate, Felbamate 600 mg/5mL suspension, listed with the FDA by NORTHSTAR RX LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

NORTHSTAR RX LLC, NDC labeler code 16714. 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 16714-775 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-775Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0775Add 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
16714-775-01	1671407750116714077501	237 mL in 1 BOTTLE (16714-775-01)Marketed from Apr 10, 2018
16714-775-02	1671407750216714077502	473 mL in 1 BOTTLE (16714-775-02)Marketed from Apr 10, 2018

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: NORTHSTAR RX LLCNDC labeler code 16714
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206314
Marketing start: Apr 10, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 16714-775_c3010d7b-f928-464e-af7c-ca45a5320a20SPL ID c3010d7b-f928-464e-af7c-ca45a5320a20SPL set ID 556de35d-3b98-48d3-a670-50e9d93437a4RxCUI 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

N416714077501 followed by a unit qualifier and the quantity

Package 16714-0775-01. 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 Apr 17, 2018. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Felbamate oral suspension, USP 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 can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epileps…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-775

What is NDC 16714-775?: 16714-775 is the product NDC for Felbamate, Felbamate 600 mg/5mL suspension, listed with the FDA by NORTHSTAR RX 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?: NORTHSTAR RX LLC, NDC labeler code 16714. 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

Other NDCs under ANDA 206314

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

FDA NDC Directory listings under ANDA 206314
Product	Strength	Form · route	Labeler	Product NDC
Felbamate	Felbamate 600 mg/5mL	SuspensionOral	Sun Pharmaceutical Industries, Inc.	51672-4172