What is NDC 16571-804?

16571-804 is the product NDC for Zolmitriptan, Zolmitriptan 5 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zolmitriptan?

37 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zolmitriptan NDC 16571-804 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-804Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0804Add 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
16571-804-13	16571080413	1 BLISTER PACK in 1 CARTON (16571-804-13) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 11, 2016

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): Zolmitriptan
Generic name (nonproprietary): zolmitriptan
Active ingredients: Zolmitriptan — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207021
Marketing start: May 11, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers: Product ID 16571-804_fcf22883-8cbb-4185-99ba-5be1bcfb9306SPL ID fcf22883-8cbb-4185-99ba-5be1bcfb9306SPL set ID 5fcdc5d6-38fa-458d-a581-4e3678a9e8fdRxCUI 200193, 200194UNII 2FS66TH3YW
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

N416571080413 followed by a unit qualifier and the quantity

Package 16571-0804-13. 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 Feb 17, 2024.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-804

What is NDC 16571-804?: 16571-804 is the product NDC for Zolmitriptan, Zolmitriptan 5 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zolmitriptan.
What is the active ingredient?: Zolmitriptan.
Who is the labeler?: Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zolmitriptan?: 37 other product NDCs are listed under this name. See all Zolmitriptan 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 Zolmitriptan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Zolmitriptan	Zolmitriptan 2.5 mg/1	Spray, MeteredNasal	Amneal Pharmaceuticals NY LLC	69238-2351	69238-2351-06
Zolmitriptan	Zolmitriptan 5 mg/1	Spray, MeteredNasal	Amneal Pharmaceuticals NY LLC	69238-2352	69238-2352-06
Zolmitriptan	Zolmitriptan 2.5 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-181	62332-0181-06
Zolmitriptan	Zolmitriptan 5 mg/1	Tablet, Orally disintegratingOral	Alembic Pharmaceuticals Inc.	62332-182	62332-0182-03
Zolmitriptan	Zolmitriptan 2.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-462	62332-0462-06
Zolmitriptan	Zolmitriptan 5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-463	62332-0463-03
Zolmitriptan	Zolmitriptan 2.5 mg/1	TabletOral	Direct_Rx	72189-434	72189-0434-06
Zolmitriptan	Zolmitriptan 5 mg/1	TabletOral	Direct_Rx	72189-435	72189-0435-03
zolmitriptan	Zolmitriptan 5 mg/1	SprayNasal	Padagis Israel Pharmaceuticals Ltd	45802-711	45802-0711-91
zolmitriptan	Zolmitriptan 5 mg/1	SprayNasal	Bryant Ranch Prepack	63629-9575	63629-9575-01

All 38 Zolmitriptan NDCs

Other NDCs under ANDA 207021

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

FDA NDC Directory listings under ANDA 207021
Product	Strength	Form · route	Labeler	Product NDC
Zolmitriptan	Zolmitriptan 2.5 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-803
Zolmitriptan	Zolmitriptan 2.5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-914
Zolmitriptan	Zolmitriptan 5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-915