What is NDC 46708-463?

46708-463 is the product NDC for Zolmitriptan, Zolmitriptan 5 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-463 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-463Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0463Add 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
46708-463-03	4670804630346708046303	3 TABLET, FILM COATED in 1 CARTON (46708-463-03)Marketed from Jan 4, 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: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204232
Marketing start: Jan 4, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers: Product ID 46708-463_edab3a0b-baf7-422c-be76-2638914d62f6SPL ID edab3a0b-baf7-422c-be76-2638914d62f6SPL set ID 75a92ce1-eade-4b71-80ab-d7fd1f57e352RxCUI 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

N446708046303 followed by a unit qualifier and the quantity

Package 46708-0463-03. 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 Jan 30, 2023.

Indications (excerpt from the label)

Zolmitriptan is indicated for the acute treatment of migraine with or without aura in adults 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. Zolmitriptan 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 46708-463

What is NDC 46708-463?: 46708-463 is the product NDC for Zolmitriptan, Zolmitriptan 5 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 204232

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

FDA NDC Directory listings under ANDA 204232
Product	Strength	Form · route	Labeler	Product NDC
Zolmitriptan	Zolmitriptan 2.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-462
Zolmitriptan	Zolmitriptan 2.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-462
Zolmitriptan	Zolmitriptan 5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-463