What is NDC 0054-0278?

0054-0278 is the product NDC for Naratriptan, Naratriptan hydrochloride 1 mg/1 tablet, 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 Naratriptan?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Naratriptan NDC 0054-0278 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0278Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0278Add 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
0054-0278-03	0005402780300054027803	9 TABLET in 1 BOTTLE (0054-0278-03)Marketed from Oct 7, 2010

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): Naratriptan
Generic name (nonproprietary): naratriptan
Active ingredients: Naratriptan hydrochloride — 1 mg/1
Dosage form: Tablet
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 090381
Marketing start: Jul 7, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers: Product ID 0054-0278_14eeba7d-700d-4ac1-a71e-d6a1fca8aaabSPL ID 14eeba7d-700d-4ac1-a71e-d6a1fca8aaabSPL set ID fd1944b3-8054-4faa-a82e-d818dfdd3875RxCUI 311918, 314135UNII 10X8X4P12Z
Pharmacologic class: Serotonin-1b and Serotonin-1d Receptor Agonist

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

N400054027803 followed by a unit qualifier and the quantity

Package 00054-0278-03. 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 Mar 3, 2023.

Indications (excerpt from the label)

Naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan, reconsider the diagnosis of migraine before naratriptan is administered to treat any subsequent attacks. • Naratriptan is not indicated for the prevention of migraine attacks. • Safety and effectiveness of naratriptan have not been established for cluster headache. Naratriptan is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0278

What is NDC 0054-0278?: 0054-0278 is the product NDC for Naratriptan, Naratriptan hydrochloride 1 mg/1 tablet, 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?: Naratriptan.
What is the active ingredient?: Naratriptan hydrochloride.
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 Naratriptan?: 7 other product NDCs are listed under this name. See all Naratriptan 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 Naratriptan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Naratriptan	Naratriptan hydrochloride 1 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-340	69452-0340-72
Naratriptan	Naratriptan hydrochloride 2.5 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-341	69452-0341-72
naratriptan	Naratriptan hydrochloride 1 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-054	23155-0054-0323155-0054-0523155-0054-19
naratriptan	Naratriptan hydrochloride 2.5 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-055	23155-0055-0323155-0055-0523155-0055-19
naratriptan	Naratriptan hydrochloride 1 mg/1	TabletOral	ASCLEMED USA INC.	87063-287	87063-0287-0987063-0287-1287063-0287-30+2 more
naratriptan	Naratriptan hydrochloride 2.5 mg/1	TabletOral	ASCLEMED USA INC.	87063-288	87063-0288-0987063-0288-1287063-0288-30+2 more
Naratriptan	Naratriptan hydrochloride 2.5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0279	00054-0279-03

Other NDCs under ANDA 090381

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

FDA NDC Directory listings under ANDA 090381
Product	Strength	Form · route	Labeler	Product NDC
Naratriptan	Naratriptan hydrochloride 2.5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0279