NDC codes

FDA NDC Directory
Product NDC (as listed)59651-563Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0563Add 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
59651-563-6059651056360596510563601 BOTTLE in 1 CARTON (59651-563-60) / 460 mL in 1 BOTTLEMarketed from Oct 26, 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)
Rufinamide
Generic name (nonproprietary)
rufinamide
Active ingredients
Rufinamide — 40 mg/mL
Dosage form
Suspension
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216549
Marketing start
Listing expires
Identifiers
Product ID 59651-563_855369b6-9f5b-4951-9115-dbb9a74ac53bSPL ID 855369b6-9f5b-4951-9115-dbb9a74ac53bSPL set ID 444544f0-7622-4eef-b218-f241bd50d4afRxCUI 1092357UNII WFW942PR79

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

N459651056360 followed by a unit qualifier and the quantity

Package 59651-0563-60. 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 .

Indications (excerpt from the label)

Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-563

What is NDC 59651-563?
59651-563 is the product NDC for Rufinamide, Rufinamide 40 mg/mL suspension, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rufinamide.
What is the active ingredient?
Rufinamide.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rufinamide?
20 other product NDCs are listed under this name. See all Rufinamide 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 Rufinamide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
RufinamideRufinamide 40 mg/mLSuspensionOralAmerican Health Packaging60687-82460687-0824-08
RufinamideRufinamide 40 mg/mLSuspensionOralNovadoz Pharmaceuticals LLC72205-03872205-0038-77
RufinamideRufinamide 40 mg/mLSuspensionOralNorthStar RxLLC72603-26172603-0261-01
RufinamideRufinamide 40 mg/mLSuspensionOralCamber Pharmaceuticals, Inc.31722-68831722-0688-46
RufinamideRufinamide 200 mg/1TabletOralMicro Labs Limited42571-39142571-0391-12
RufinamideRufinamide 400 mg/1TabletOralMicro Labs Limited42571-39242571-0392-12
RufinamideRufinamide 40 mg/mLSuspensionOralLupin Pharmaceuticals, Inc.68180-79768180-0797-01
RufinamideRufinamide 200 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-61659651-0616-08
RufinamideRufinamide 400 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-61759651-0617-08
RufinamideRufinamide 200 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-80368180-0803-16

All 21 Rufinamide NDCs

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