Prescription drug · ANDA
Naratriptan NDC 69452-341
Naratriptan hydrochloride 2.5 mg/1 · Tablet, Film coated · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-341-72 | 6945203417269452034172 | 1 BLISTER PACK in 1 CARTON (69452-341-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-341-60)Marketed from Apr 11, 2022 |
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)
- Naratriptan
- Generic name (nonproprietary)
- naratriptan
- Active ingredients
- Naratriptan hydrochloride — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091441
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69452-341_f91320a2-bfdd-4b9e-a68f-5ec94b77263bSPL ID f91320a2-bfdd-4b9e-a68f-5ec94b77263bSPL set ID 93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6ddaRxCUI 311918, 314135UNII 10X8X4P12Z
- 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
N469452034172followed by a unit qualifier and the quantityPackage 69452-0341-72. 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)
Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks. Naratriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of naratriptan tablets have not been established for cluster headache. Naratriptan tablets are a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or with…
Excerpt only. Read the full label for complete information.
About NDC 69452-341
- What is NDC 69452-341?
- 69452-341 is the product NDC for Naratriptan, Naratriptan hydrochloride 2.5 mg/1 tablet, film coated, listed with the FDA by Bionpharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naratriptan.
- What is the active ingredient?
- Naratriptan hydrochloride.
- Who is the labeler?
- Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naratriptan?
- 7 other product NDCs are listed under this name. See all Naratriptan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naratriptan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naratriptan | Naratriptan hydrochloride 1 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-340 | 69452-0340-72 |
| naratriptan | Naratriptan hydrochloride 1 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-054 | 23155-0054-0323155-0054-0523155-0054-19 |
| naratriptan | Naratriptan hydrochloride 2.5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-055 | 23155-0055-0323155-0055-0523155-0055-19 |
| naratriptan | Naratriptan hydrochloride 1 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-287 | 87063-0287-0987063-0287-1287063-0287-30+2 more |
| naratriptan | Naratriptan hydrochloride 2.5 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-288 | 87063-0288-0987063-0288-1287063-0288-30+2 more |
| Naratriptan | Naratriptan hydrochloride 1 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0278 | 00054-0278-03 |
| Naratriptan | Naratriptan hydrochloride 2.5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0279 | 00054-0279-03 |
Other NDCs under ANDA 091441
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 |
|---|---|---|---|---|
| Naratriptan | Naratriptan hydrochloride 1 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-340 |