Prescription drug · ANDA
Zolmitriptan NDC 65841-768
Zolmitriptan 5 mg/1 · Tablet, Orally disintegrating · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-768-01 | 6584107680165841076801 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-01)Marketed from May 16, 2013 | |
| 65841-768-06 | 6584107680665841076806 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-06)Marketed from May 16, 2013 | |
| 65841-768-10 | 6584107681065841076810 | 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-10)Marketed from May 16, 2013 | |
| 65841-768-16 | 6584107681665841076816 | 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-16)Marketed from May 16, 2013 | |
| 65841-768-77 | 6584107687765841076877 | 10 BLISTER PACK in 1 CARTON (65841-768-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-768-30)Marketed from May 16, 2013 | |
| 65841-768-82 | 6584107688265841076882 | 1 BLISTER PACK in 1 CARTON (65841-768-82) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-768-87)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 — 5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 65841
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202890
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 65841-768_31419037-52ae-41bb-a03e-8965205ab347SPL ID 31419037-52ae-41bb-a03e-8965205ab347SPL set ID aae2d9cb-9938-4032-961f-f0afd1958b5dRxCUI 284201, 351134UNII 2FS66TH3YWUPC 0365841768060
- 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
N465841076801followed by a unit qualifier and the quantityPackage 65841-0768-01. 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 .
About NDC 65841-768
- What is NDC 65841-768?
- 65841-768 is the product NDC for Zolmitriptan, Zolmitriptan 5 mg/1 tablet, orally disintegrating, listed with the FDA by Zydus Lifesciences Limited. 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 Lifesciences Limited, NDC labeler code 65841. 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 202890
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, Orally disintegratingOral | Zydus Lifesciences Limited | 65841-767 |
| Zolmitriptan | Zolmitriptan 2.5 mg/1 | Tablet, Orally disintegratingOral | Zydus Pharmaceuticals USA Inc. | 68382-715 |
| Zolmitriptan | Zolmitriptan 5 mg/1 | Tablet, Orally disintegratingOral | Zydus Pharmaceuticals USA Inc. | 68382-717 |