Prescription drug · ANDA
Zolmitriptan NDC 68001-250
Zolmitriptan 5 mg/1 · Tablet, Film coated · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-250-01 | 6800102500168001025001 | 1 BLISTER PACK in 1 CARTON (68001-250-01) / 3 TABLET, FILM COATED in 1 BLISTER PACK (68001-250-18)Marketed from Mar 13, 2014 |
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
- BluePoint LaboratoriesNDC labeler code 68001
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201779
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68001-250_4f68e4d5-c239-eb2d-e063-6294a90af478SPL ID 4f68e4d5-c239-eb2d-e063-6294a90af478SPL set ID e6628b7a-0b63-4e6f-a5e7-2fa195265235RxCUI 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
N468001025001followed by a unit qualifier and the quantityPackage 68001-0250-01. 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 .
Indications (excerpt from the label)
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 before zolmitriptan tablets are administered to treat any subsequent attacks. Zolmitriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache. Zolmitriptan tablets are a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatme…
Excerpt only. Read the full label for complete information.
About NDC 68001-250
- What is NDC 68001-250?
- 68001-250 is the product NDC for Zolmitriptan, Zolmitriptan 5 mg/1 tablet, film coated, listed with the FDA by BluePoint Laboratories. 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?
- BluePoint Laboratories, NDC labeler code 68001. 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.
Related NDCs: other Zolmitriptan products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 201779
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 |
|---|---|---|---|---|
| Zolmitriptan | Zolmitriptan 2.5 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-249 |
| Zolmitriptan | Zolmitriptan 2.5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc.,USA | 68462-497 |
| Zolmitriptan | Zolmitriptan 5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc.,USA | 68462-498 |