What is NDC 68382-715?

68382-715 is the product NDC for Zolmitriptan, Zolmitriptan 2.5 mg/1 tablet, orally disintegrating, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 68382-715 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-715Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0715Add 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
68382-715-01	6838207150168382071501	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-01)Marketed from May 16, 2013
68382-715-06	6838207150668382071506	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-06)Marketed from May 16, 2013
68382-715-10	6838207151068382071510	1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-10)Marketed from May 16, 2013
68382-715-16	6838207151668382071516	90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-16)Marketed from May 16, 2013
68382-715-77	6838207157768382071577	10 BLISTER PACK in 1 CARTON (68382-715-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-715-30)Marketed from May 16, 2013
68382-715-86	6838207158668382071586	1 BLISTER PACK in 1 CARTON (68382-715-86) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-715-69)Marketed from May 16, 2013

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, Orally disintegrating
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202890
Marketing start: May 16, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers: Product ID 68382-715_c8bbe1ff-34e4-4638-ac8a-00b1ceb2f310SPL ID c8bbe1ff-34e4-4638-ac8a-00b1ceb2f310SPL set ID 7fc95729-2f5d-4d5c-b26c-3a13854f73e3RxCUI 284201, 351134UNII 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

N468382071501 followed by a unit qualifier and the quantity

Package 68382-0715-01. 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 8, 2023.

Indications (excerpt from the label)

Zolmitriptan orally disintegrating tablets are a 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 orally disintegrating tablets are 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, …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-715

What is NDC 68382-715?: 68382-715 is the product NDC for Zolmitriptan, Zolmitriptan 2.5 mg/1 tablet, orally disintegrating, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 package NDCs, 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 202890

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

FDA NDC Directory listings under ANDA 202890
Product	Strength	Form · route	Labeler	Product NDC
Zolmitriptan	Zolmitriptan 2.5 mg/1	Tablet, Orally disintegratingOral	Zydus Lifesciences Limited	65841-767
Zolmitriptan	Zolmitriptan 5 mg/1	Tablet, Orally disintegratingOral	Zydus Lifesciences Limited	65841-768
Zolmitriptan	Zolmitriptan 5 mg/1	Tablet, Orally disintegratingOral	Zydus Pharmaceuticals USA Inc.	68382-717