What is NDC 69097-863?

69097-863 is the product NDC for Zolmitriptan, Zolmitriptan 2.5 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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 69097-863 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-863Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0863Add 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
69097-863-17	6909708631769097086317	1 BLISTER PACK in 1 CARTON (69097-863-17) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 20, 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 — 2.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204284
Marketing start: Jul 20, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers: Product ID 69097-863_dcf24dee-fe87-4adf-b572-16c08868a355SPL ID dcf24dee-fe87-4adf-b572-16c08868a355SPL set ID 16e520fe-2f57-400b-8ee5-9a3f89037d6cRxCUI 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

N469097086317 followed by a unit qualifier and the quantity

Package 69097-0863-17. 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 Oct 29, 2019.

Indications (excerpt from the label)

Zolmitriptan is serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use : Use only after a clear diagnosis of migraine has been established ( 1 ) Not indicated for the prophylactic therapy of migraine ( 1 ) Not indicated for the treatment of cluster headache ( 1 ) 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 b…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-863

What is NDC 69097-863?: 69097-863 is the product NDC for Zolmitriptan, Zolmitriptan 2.5 mg/1 tablet, film coated, listed with the FDA by Cipla USA 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?: Cipla USA Inc., NDC labeler code 69097. 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 204284

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

FDA NDC Directory listings under ANDA 204284
Product	Strength	Form · route	Labeler	Product NDC
Zolmitriptan	Zolmitriptan 5 mg/1	Tablet, Film coatedOral	Cipla USA Inc.	69097-864