Prescription drug · ANDA
zolmiptriptan (Zolmitriptan) NDC 68462-500
Zolmitriptan 5 mg/1 · Tablet, Orally disintegrating · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-500-33 | 6846205003368462050033 | 1 BLISTER PACK in 1 CARTON (68462-500-33) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68462-500-40)Marketed from May 14, 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)
- zolmiptriptan
- Generic name (nonproprietary)
- zolmitriptan
- Active ingredients
- Zolmitriptan — 5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202560
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68462-500_977ca814-2c55-4de0-a75e-9e42f2e86f77SPL ID 977ca814-2c55-4de0-a75e-9e42f2e86f77SPL set ID a734b368-6008-441c-ab44-5634e46be9a4RxCUI 284201, 351134UNII 2FS66TH3YWUPC 0368462499764, 0368462500330
- 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
N468462050033followed by a unit qualifier and the quantityPackage 68462-0500-33. 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 .
Indications (excerpt from the label)
Zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use • Only use zolmitriptan orally disintegrating tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan orally disintegrating tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan orally disintegrating tablets are administered to treat any subsequent attacks. • Zolmitriptan orally disintegrating tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of zolmitriptan orally disintegrating tablets have not been esta…
Excerpt only. Read the full label for complete information.
About NDC 68462-500
- What is NDC 68462-500?
- 68462-500 is the product NDC for zolmiptriptan (zolmitriptan), Zolmitriptan 5 mg/1 tablet, orally disintegrating, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- zolmiptriptan (Zolmitriptan).
- What is the active ingredient?
- Zolmitriptan.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for zolmiptriptan?
- 1 other product NDC are listed under this name. See all zolmiptriptan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other zolmiptriptan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| zolmiptriptanzolmitriptan | Zolmitriptan 2.5 mg/1 | Tablet, Orally disintegratingOral | Glenmark Pharmaceuticals Inc., USA | 68462-499 | 68462-0499-76 |
Other NDCs under ANDA 202560
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| zolmiptriptanzolmitriptan | Zolmitriptan 2.5 mg/1 | Tablet, Orally disintegratingOral | Glenmark Pharmaceuticals Inc., USA | 68462-499 |