Prescription drug · ANDA
Sumatriptan and Naproxen Sodium NDC 47335-410
Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-410-22 | 47335041022 | 9 TABLET, FILM COATED in 1 BOTTLE (47335-410-22)Marketed from Jul 20, 2018 | |
| 47335-410-83 | 47335041083 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-410-83)Marketed from Jul 20, 2018 | |
| 47335-410-88 | 47335041088 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-410-88)Marketed from Jul 20, 2018 |
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)
- Sumatriptan and Naproxen Sodium
- Generic name (nonproprietary)
- sumatriptan and naproxen sodium
- Active ingredients
- Sumatriptan succinate — 85 mg/1Naproxen sodium — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202803
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
- Identifiers
- Product ID 47335-410_c67d3234-28c7-40a9-a472-87747bb4242aSPL ID c67d3234-28c7-40a9-a472-87747bb4242aSPL set ID 96ed12a3-fa76-4afd-bee8-1ab19eb607f3RxCUI 849450UNII J8BDZ68989, 9TN87S3A3CUPC 0347335410228
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; 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
N447335041022followed by a unit qualifier and the quantityPackage 47335-0410-22. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks. Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established…
Excerpt only. Read the full label for complete information.
About NDC 47335-410
- What is NDC 47335-410?
- 47335-410 is the product NDC for Sumatriptan and Naproxen Sodium, Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sumatriptan and Naproxen Sodium.
- What is the active ingredient?
- Sumatriptan succinate, Naproxen sodium.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sumatriptan and Naproxen Sodium?
- 2 other product NDCs are listed under this name. See all Sumatriptan and Naproxen Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sumatriptan and Naproxen Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sumatriptan and Naproxen Sodium | Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-891 | 16714-0891-01 |
| Sumatriptan and Naproxen Sodium | Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-928 | 65862-0928-36 |
Other NDCs under ANDA 202803
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 |
|---|---|---|---|---|
| Sumatriptan and Naproxen Sodium | Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-891 |