What is NDC 69097-865?

69097-865 is the product NDC for Rizatriptan Benzoate, Rizatriptan benzoate 5 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, 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 Rizatriptan Benzoate?

56 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rizatriptan Benzoate NDC 69097-865

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-865Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0865Add 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
69097-865-17	6909708651769097086517	6 TABLET in 1 BLISTER PACK (69097-865-17)Marketed from Jul 22, 2016
69097-865-85	6909708658569097086585	3 TABLET in 1 CARTON (69097-865-85)Marketed from Jul 22, 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): Rizatriptan Benzoate
Generic name (nonproprietary): rizatriptan benzoate
Active ingredients: Rizatriptan benzoate — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204339
Marketing start: Jul 22, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers: Product ID 69097-865_6ace7fac-e700-4a32-95ce-07ffbd0201eaSPL ID 6ace7fac-e700-4a32-95ce-07ffbd0201eaSPL set ID f462a507-921c-41c2-93ba-36003b6e8914RxCUI 312840, 314209UNII WR978S7QHH
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

N469097086517 followed by a unit qualifier and the quantity

Package 69097-0865-17. 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 Jan 13, 2022.

Indications (excerpt from the label)

Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age ( 1 ) Limitations of Use : Use only after 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) Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a pati…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-865

What is NDC 69097-865?: 69097-865 is the product NDC for Rizatriptan Benzoate, Rizatriptan benzoate 5 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rizatriptan Benzoate.
What is the active ingredient?: Rizatriptan benzoate.
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 Rizatriptan Benzoate?: 56 other product NDCs are listed under this name. See all Rizatriptan Benzoate 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 Rizatriptan Benzoate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rizatriptan Benzoate	Rizatriptan benzoate 10 mg/1	Tablet, Orally disintegratingOral	Advanced Rx of Tennessee, LLC	80425-0535	80425-0535-01
Rizatriptan Benzoate	Rizatriptan benzoate 10 mg/1	Tablet, Orally disintegratingOral	REMEDYREPACK INC.	70518-4362	70518-4362-00
Rizatriptan Benzoate	Rizatriptan benzoate 5 mg/1	TabletOral	Direct_Rx	72189-512	72189-0512-18
Rizatriptan Benzoate	Rizatriptan benzoate 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-447	72189-0447-18
Rizatriptan Benzoate	Rizatriptan benzoate 5 mg/1	TabletOral	Direct Rx	72189-316	72189-0316-18
Rizatriptan Benzoate	Rizatriptan benzoate 10 mg/1	TabletOral	direct rx	72189-258	72189-0258-1272189-0258-18
Rizatriptan Benzoate	Rizatriptan benzoate 10 mg/1	TabletOral	DIRECT RX	61919-656	61919-0656-12
Rizatriptan Benzoate	Rizatriptan benzoate 5 mg/1	TabletOral	DIRECT RX	61919-394	61919-0394-18
Rizatriptan Benzoate	Rizatriptan benzoate 5 mg/1	Tablet, Orally disintegratingOral	Unichem Pharmaceuticals (USA), Inc.	29300-268	29300-0268-2129300-0268-8129300-0268-91
Rizatriptan Benzoate	Rizatriptan benzoate 10 mg/1	Tablet, Orally disintegratingOral	Unichem Pharmaceuticals (USA), Inc.	29300-269	29300-0269-2129300-0269-8129300-0269-91

All 57 Rizatriptan Benzoate NDCs

Other NDCs under ANDA 204339

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

FDA NDC Directory listings under ANDA 204339
Product	Strength	Form · route	Labeler	Product NDC
Rizatriptan Benzoate	Rizatriptan benzoate 5 mg/1	TabletOral	DIRECT RX	61919-394
Rizatriptan Benzoate	Rizatriptan benzoate 10 mg/1	TabletOral	Cipla USA Inc.	69097-866