NDC codes

FDA NDC Directory
Product NDC (as listed)68180-797Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0797Add 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
68180-797-0168180079701681800797011 BOTTLE in 1 CARTON (68180-797-01) / 460 mL in 1 BOTTLEMarketed from Jun 22, 2023

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
Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213457
Marketing start
Listing expires
Identifiers
Product ID 68180-797_47c9752b-a06d-46af-a029-9213e2474378SPL ID 47c9752b-a06d-46af-a029-9213e2474378SPL set ID 1e671632-d5bd-499a-ba06-0d1dc0d99622RxCUI 1092357UNII WFW942PR79UPC 0368180797012

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

N468180079701 followed by a unit qualifier and the quantity

Package 68180-0797-01. 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 .

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 68180-797

What is NDC 68180-797?
68180-797 is the product NDC for Rufinamide, Rufinamide 40 mg/mL suspension, listed with the FDA by Lupin Pharmaceuticals, Inc.. 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?
Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 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
RufinamideRufinamide 400 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-80468180-0804-16

All 21 Rufinamide NDCs

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