NDC codes

FDA NDC Directory
Product NDC (as listed)51672-4185Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-4185Add 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
51672-4185-15167241850151672418501100 TABLET in 1 BOTTLE (51672-4185-1)Marketed from Apr 20, 2017
51672-4185-6516724185065167241850630 TABLET in 1 BOTTLE (51672-4185-6)Marketed from Apr 20, 2017

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
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207093
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 51672-4185_535716aa-d92d-98e9-e063-6294a90a7826SPL ID 535716aa-d92d-98e9-e063-6294a90a7826SPL set ID f2edb3ed-da20-4093-88ea-00fe781e47e0RxCUI 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

N451672418501 followed by a unit qualifier and the quantity

Package 51672-4185-01. 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 is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate 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 epilepsy and as adjunctive ther…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51672-4185

What is NDC 51672-4185?
51672-4185 is the product NDC for Felbamate, Felbamate 400 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FelbamateFelbamate 400 mg/1TabletOralAmneal Pharmaceuticals of New York LLC53746-73453746-0734-3053746-0734-90
FelbamateFelbamate 600 mg/1TabletOralAmneal Pharmaceuticals of New York LLC53746-73553746-0735-1853746-0735-3053746-0735-90
FelbamateFelbamate 600 mg/5mLSuspensionOralNovitium Pharma LLC70954-05170954-0051-1070954-0051-20
FelbamateFelbamate 400 mg/1TabletOralViona Pharmaceuticals Inc72578-05672578-0056-0172578-0056-0572578-0056-06+2 more
FelbamateFelbamate 600 mg/1TabletOralViona Pharmaceuticals Inc72578-05772578-0057-0172578-0057-0572578-0057-06+3 more
FelbamateFelbamate 400 mg/1TabletOralANI Pharmaceuticals, Inc.62559-73062559-0730-01
FelbamateFelbamate 600 mg/1TabletOralANI Pharmaceuticals, Inc.62559-73162559-0731-01
FelbamateFelbamate 400 mg/1TabletOralBryant Ranch Prepack63629-193763629-1937-01
FelbamateFelbamate 600 mg/1TabletOralBryant Ranch Prepack63629-194463629-1944-01
FelbamateFelbamate 400 mg/1TabletOralBryant Ranch Prepack72162-177072162-1770-01

All 20 Felbamate NDCs

Other NDCs under ANDA 207093

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

FDA NDC Directory listings under ANDA 207093
ProductStrengthForm · routeLabelerProduct NDC
FelbamateFelbamate 600 mg/1TabletOralSun Pharmaceutical Industries, Inc.51672-4186

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