Prescription drug · ANDA
naratriptan NDC 23155-054
Naratriptan hydrochloride 1 mg/1 · Tablet · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-054-03 | 2315500540323155005403 | 30 TABLET in 1 BOTTLE (23155-054-03)Marketed from Mar 15, 2011 | |
| 23155-054-05 | 2315500540523155005405 | 500 TABLET in 1 BOTTLE (23155-054-05)Marketed from Mar 15, 2011 | |
| 23155-054-19 | 2315500541923155005419 | 9 TABLET in 1 BLISTER PACK (23155-054-19)Marketed from Mar 15, 2011 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDC labeler code 23155
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200502
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 23155-054_61e37b1d-f036-4c35-9073-ce456efd8007SPL ID 61e37b1d-f036-4c35-9073-ce456efd8007SPL set ID 41c29652-32f8-48dc-9038-0e2195aa2084RxCUI 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
N423155005403followed by a unit qualifier and the quantityPackage 23155-0054-03. 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 serotonin (5-HT 1B/1D ) receptor agonists (triptan) indicated for the acute treatment of migraine with or witho…
Excerpt only. Read the full label for complete information.
About NDC 23155-054
- What is NDC 23155-054?
- 23155-054 is the product NDC for naratriptan, Naratriptan hydrochloride 1 mg/1 tablet, listed with the FDA by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. It has 3 package NDCs, 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?
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., NDC labeler code 23155. 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 2.5 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-341 | 69452-0341-72 |
| 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 200502
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 2.5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-055 |
| naratriptan | Naratriptan hydrochloride 1 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-287 |
| naratriptan | Naratriptan hydrochloride 2.5 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-288 |