NDC codes

FDA NDC Directory
Product NDC (as listed)63629-1937Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-1937Add 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 NDC11-digit (billing)PackageCopy
63629-1937-163629193701100 TABLET in 1 BOTTLE (63629-1937-1)Marketed from Jan 14, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202284
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 63629-1937_63650268-9456-4e13-aa31-75a222c53142SPL ID 63650268-9456-4e13-aa31-75a222c53142SPL set ID 6afd77f2-4525-42f4-a4b1-94159c401dd2RxCUI 198358UNII 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

N463629193701 followed by a unit qualifier and the quantity

Package 63629-1937-01. 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 . 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 epilep…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202284

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

FDA NDC Directory listings under ANDA 202284
ProductStrengthForm · routeLabelerProduct NDC
FelbamateFelbamate 600 mg/1TabletOralBryant Ranch Prepack72162-1771
FelbamateFelbamate 400 mg/1TabletOralBryant Ranch Prepack72162-1770
FelbamateFelbamate 600 mg/1TabletOralANI Pharmaceuticals, Inc.62559-731
FelbamateFelbamate 400 mg/1TabletOralANI Pharmaceuticals, Inc.62559-730
FelbamateFelbamate 600 mg/1TabletOralBryant Ranch Prepack63629-1944

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