Prescription drug · ANDA
Zomig (Zolmitriptan) NDC 60846-130
Zolmitriptan 2.5 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60846-130-30 | 6084601303060846013030 | 1 BLISTER PACK in 1 CARTON (60846-130-30) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 9, 2023 |
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)
- Zomig
- Generic name (nonproprietary)
- zolmitriptan
- Active ingredients
- Zolmitriptan — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 60846
- 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 60846-130_dc410bf4-cff9-473c-95f1-4b0412bf05f3SPL ID dc410bf4-cff9-473c-95f1-4b0412bf05f3SPL set ID 1d977430-f494-415d-9daf-3c3163156249RxCUI 153353, 200193, 200194, 213167UNII 2FS66TH3YWUPC 0360846133608, 0360846130300
- 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
N460846013030followed by a unit qualifier and the quantityPackage 60846-0130-30. 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)
ZOMIG is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Only use ZOMIG if a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks. ZOMIG is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG have not been established for cluster headache. ZOMIG is 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 mi…
Excerpt only. Read the full label for complete information.
About NDC 60846-130
- What is NDC 60846-130?
- 60846-130 is the product NDC for Zomig (zolmitriptan), Zolmitriptan 2.5 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zomig (Zolmitriptan).
- What is the active ingredient?
- Zolmitriptan.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 60846. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zomig?
- 1 other product NDC are listed under this name. See all Zomig NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zomig products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zomigzolmitriptan | Zolmitriptan 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 60846-133 | 60846-0133-60 |
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 2.5 mg/1 | Tablet, Film coatedOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0101 |
| 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 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 60846-133 |