zolmitriptan NDC 45802-711

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-711Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0711Add 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
45802-711-91	45802071191	6 BOTTLE, SPRAY in 1 CARTON (45802-711-91) / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00)Marketed from Nov 16, 2021

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: Spray
Route: Nasal
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212469
Marketing start: Nov 16, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers: Product ID 45802-711_670da414-66ad-4c5f-b218-f4958daae12cSPL ID 670da414-66ad-4c5f-b218-f4958daae12cSPL set ID 24e12658-eb42-4d1f-9192-9c4298416d51RxCUI 402000UNII 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N445802071191 followed by a unit qualifier and the quantity

Package 45802-0711-91. 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 Nov 1, 2022.

Indications (excerpt from the label)

Zolmitriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: • Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. • Zolmitriptan is not indicated for the prevention of migraine attacks. • Safety and effectiveness of zolmitriptan have not been established for cluster headache. • Not recommended in patients with moderate or severe hepatic impairment [ see Dosage and A…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212469

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

FDA NDC Directory listings under ANDA 212469
Product	Strength	Form · route	Labeler	Product NDC
zolmitriptan	Zolmitriptan 5 mg/1	SprayNasal	Bryant Ranch Prepack	72162-1425
zolmitriptan	Zolmitriptan 5 mg/1	SprayNasal	Bryant Ranch Prepack	71335-2947
zolmitriptan	Zolmitriptan 5 mg/1	SprayNasal	Bryant Ranch Prepack	63629-9575