What is NDC 0054-0528?

0054-0528 is the product NDC for Rufinamide, Rufinamide 40 mg/mL suspension, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rufinamide NDC 0054-0528 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0528Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0528Add 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
0054-0528-63	0005405286300054052863	1 BOTTLE in 1 CARTON (0054-0528-63) / 460 mL in 1 BOTTLEMarketed from Nov 1, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207363
Marketing start: Nov 1, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 0054-0528_eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80SPL ID eb1cdda2-10c1-4acc-ab6a-c6aba2c7db80SPL set ID 8ef75997-06f6-441f-8320-a23bc13ca2d9RxCUI 1092357UNII WFW942PR79UPC 0300540528638

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

N400054052863 followed by a unit qualifier and the quantity

Package 00054-0528-63. 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 Sep 5, 2020.

Indications (excerpt from the label)

Rufinamide 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 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 0054-0528

What is NDC 0054-0528?: 0054-0528 is the product NDC for Rufinamide, Rufinamide 40 mg/mL suspension, listed with the FDA by Hikma Pharmaceuticals USA 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rufinamide	Rufinamide 40 mg/mL	SuspensionOral	American Health Packaging	60687-824	60687-0824-08
Rufinamide	Rufinamide 40 mg/mL	SuspensionOral	Novadoz Pharmaceuticals LLC	72205-038	72205-0038-77
Rufinamide	Rufinamide 40 mg/mL	SuspensionOral	NorthStar RxLLC	72603-261	72603-0261-01
Rufinamide	Rufinamide 40 mg/mL	SuspensionOral	Camber Pharmaceuticals, Inc.	31722-688	31722-0688-46
Rufinamide	Rufinamide 200 mg/1	TabletOral	Micro Labs Limited	42571-391	42571-0391-12
Rufinamide	Rufinamide 400 mg/1	TabletOral	Micro Labs Limited	42571-392	42571-0392-12
Rufinamide	Rufinamide 40 mg/mL	SuspensionOral	Lupin Pharmaceuticals, Inc.	68180-797	68180-0797-01
Rufinamide	Rufinamide 200 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-616	59651-0616-08
Rufinamide	Rufinamide 400 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-617	59651-0617-08
Rufinamide	Rufinamide 200 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-803	68180-0803-16

All 21 Rufinamide NDCs

Other NDCs under ANDA 207363

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

FDA NDC Directory listings under ANDA 207363
Product	Strength	Form · route	Labeler	Product NDC
Rufinamide	Rufinamide 40 mg/mL	SuspensionOral	American Health Packaging	60687-824