Prescription drug · ANDA
Zolmitriptan NDC 63548-0101
Zolmitriptan 2.5 mg/1 · Tablet, Film coated · Oral · PLD Acquisitions LLC DBA Avma Pharma Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63548-0101-6 | 6354801010663548010106 | 1 BLISTER PACK in 1 CARTON (63548-0101-6) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 27, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- PLD Acquisitions LLC DBA Avma Pharma SolutionsNDC labeler code 63548
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207867
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63548-0101_bf9467df-5c81-4b04-8ca3-e3f9104132e9SPL ID bf9467df-5c81-4b04-8ca3-e3f9104132e9SPL set ID f59bfbdd-7f4b-4a29-8396-e144dde65878RxCUI 200193, 200194UNII 2FS66TH3YWUPC 0363548010239, 0363548010161
- 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
N463548010106followed by a unit qualifier and the quantityPackage 63548-0101-06. 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 63548-0101
- What is NDC 63548-0101?
- 63548-0101 is the product NDC for Zolmitriptan, Zolmitriptan 2.5 mg/1 tablet, film coated, listed with the FDA by PLD Acquisitions LLC DBA Avma Pharma Solutions. 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?
- PLD Acquisitions LLC DBA Avma Pharma Solutions, NDC labeler code 63548. 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 207867
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 5 mg/1 | Tablet, Film coatedOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0102 |
| Zolmitriptan | Zolmitriptan 2.5 mg/1 | Tablet, Film coatedOral | Medstone Pharma LLC | 71626-101 |
| Zolmitriptan | Zolmitriptan 5 mg/1 | Tablet, Film coatedOral | Medstone Pharma LLC | 71626-102 |
| Zomigzolmitriptan | Zolmitriptan 2.5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 60846-130 |
| Zomigzolmitriptan | Zolmitriptan 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 60846-133 |